An Interventional, Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia (RESTORE)

The primary objective of this study is to evaluate the effect of immunosuppressive therapy (IST) in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness (LoE).

Start Date29 Jul 2026

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

NCT06348147

/ SuspendedPhase 2

An Attenuated Schedule Dara-RVd Induction for Patients With Newly Diagnosed Multiple Myeloma Who Are Eligible for Autologous Stem Cell Transplantation

This Phase II hybrid decentralized trial will examine the effect of daratumumab-based quadruplet induction therapy administered at an attenuated schedule in subjects with newly diagnosed multiple myeloma (NDMM) who are eligible for standard-of-care autologous stem cell transplantation (ASCT). Daratumumab, lenalidomide, bortezomib, and dexamethasone (Dara-RVd) have recently become a standard induction regimen for patients with NDMM who are eligible for ASCT in the United States. As implemented in clinical trials, Dara-RVd involves twice weekly bortezomib administration, which is inconvenient for patients and may result in increased rates of limiting toxicity, such as peripheral neuropathy. Adoption of alternate schedules involving once-weekly bortezomib is common in real-world practice, however a paucity of prospective data supporting this practice exists.
This study examines the efficacy of an attenuated Dara-RVd schedule involving once-weekly bortezomib dosing.

Start Date01 Jul 2026

Sponsor / Collaborator

Lineberger Comprehensive Cancer Center

NCT07072585

/ Not yet recruitingPhase 2/3IIT

A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)

This phase II/III trial tests the addition of daratumumab to chemotherapy for treating patients with newly-diagnosed T-ALL and T-LL. Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with daratumumab may kill more cancer cells.

Start Date28 Jun 2026

Sponsor / Collaborator

The Children's Oncology Group Foundation, Inc.

100 Clinical Results associated with Bortezomib

100 Translational Medicine associated with Bortezomib

100 Patents (Medical) associated with Bortezomib

12,519

Literatures (Medical) associated with Bortezomib

31 Dec 2026·ANNALS OF MEDICINE

Frequency-adjusted daratumumab-based regimen versus bortezomib/dexamethasone in newly diagnosed AL amyloidosis: a matched-cohort study

Article

Author: Li, Wenjing ; Zhou, Meilan ; Zheng, Wanting ; Liu, Baojian ; Zhao, Jin ; Xing, Yan ; Sun, Shiren

BACKGROUND:

The optimal dosing schedule for daratumumab (Dara) in newly diagnosed systemic light-chain (AL) amyloidosis requires refinement. This real-world study compared the efficacy and safety of a frequency-adjusted, cyclophosphamide-free Dara-based regimen with bortezomib/dexamethasone (BD).

METHODS:

We included newly diagnosed AL amyloidosis patients treated between January 2018 and December 2024, with follow-up data censored in August 2025. Using 1:1 propensity score matching based on age, cardiac stage, dFLC, and organ function, we compared hematologic/organ responses and survival. Survival was analyzed with Kaplan-Meier and log-rank tests. The Dara-based group received a cyclophosphamide-free regimen with an adjusted schedule (biweekly in cycle 1, then monthly) and a response-guided treatment duration.

RESULTS:

A total of 105 patients were included. After propensity score matching, 60 patients (30 per group) were selected for comparative analysis. The Dara-based group achieved significantly higher hematologic complete response (CR) rates at 6 months (57% vs. 27%, p = 0.018) and 12 months (63% vs. 27%, p = 0.002), with a markedly shorter median time to CR (61 vs. 120 days, p = 0.010). Organ responses were also superior: cardiac response 52% vs. 24% (p = 0.037) and renal response 56% vs. 27% (p = 0.037). No significant survival difference was observed during follow-up, and the safety profile was comparable between groups.

CONCLUSION:

A frequency-adjusted Dara-based regimen induces significantly faster and deeper hematologic and organ responses compared to BD in newly diagnosed AL amyloidosis which offers a promising personalized approach to reduce treatment burden and adverse events while maintaining high efficacy, supporting its integration into clinical practice for a broader patient population.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Indirect treatment comparison of DVRd plus DR maintenance (PERSEUS study) versus DVTd or VTd with or without lenalidomide maintenance in transplant-eligible patients with previously untreated multiple myeloma

Article

Author: Einsele, Hermann ; Facon, Thierry ; Nair, Sandhya ; Dimopoulos, Meletios A. ; He, Jianming ; Caillot, Denis ; Sonneveld, Pieter ; Zweegman, Sonja ; Ammann, Eric ; Spencer, Andrew ; Nobrega, Marjorie ; Broijl, Annemiek ; Perrot, Aurore ; Schjesvold, Fredrik ; Gay, Francesca ; Boccadoro, Mario ; Hajek, Roman ; Rodriguez-Otero, Paula ; Hulin, Cyrille ; Sitthi-Amorn, Anna ; Rowe, Melissa ; Leleu, Xavier ; Mina, Roberto

AIMS:

To compare the effectiveness of induction and consolidation with daratumumab, bortezomib, lenalidomide, and dexamethasone (DVRd) plus maintenance therapy with daratumumab and lenalidomide (DR) with 2 treatment regimens that are widely used for transplant-eligible newly diagnosed multiple myeloma (TE NDMM): bortezomib, thalidomide, and dexamethasone (VTd) or daratumumab-VTd (DVTd) followed by observation (Obs) or lenalidomide maintenance.

MATERIALS AND METHODS:

Individual patient-level data from the PERSEUS (NCT03710603) and CASSIOPEIA (NCT02541383) trials were used to compare DVRd + DR with VTd + Obs and with DVTd + Obs. Inverse probability of treatment weighting was used to adjust for differences in baseline patient characteristics between the two trials; inverse probability of censoring weighting was used to adjust for the second randomization of CASSIOPEIA. Data from the CASSIOPEIA and Myeloma XI (EudraCT 2009-010956-93) trials were combined to model outcomes associated with lenalidomide (R) maintenance following induction with DVTd or VTd.

RESULTS:

DVRd + DR showed superior progression-free survival compared with DVTd + Obs (hazard ratio, 0.39 [95% CI = 0.26-0.59]), VTd + Obs (0.17 [95% CI = 0.12-0.25]), DVTd + R (0.62 [95% CI = 0.41-0.92]), and VTd + R (0.29 [95% CI = 0.18-0.43]). Sensitivity analyses showed results were consistent with the base case.

LIMITATIONS:

The indirect treatment comparison was unanchored due to a lack of common comparators and relied on external data from the Myeloma XI trial to model outcomes associated with DVTd or VTd followed by R maintenance. Despite best efforts to identify and adjust for important treatment effect modifiers, there is a potential for residual confounding.

CONCLUSIONS:

Findings from this study suggest that DVRd followed by DR maintenance offers superior survival outcomes compared with current standards of care in TE patients with NDMM.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Inhibition of interleukin-1 receptor-associated kinase (IRAK)-4 provides partial rescue of interleukin-1 beta induced functional and gene expression changes in equine tenocytes

Article

Author: Guest, Deborah Jane ; Beaumont, Ross Eric ; Flood, Caroline

Abstract:

Background:

Interleukin 1 beta (IL-1β) is upregulated following a tendon injury and in vitro studies have shown that it leads to numerous negative effects on tendon cell function and gene expression. IL-1β activates nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) and we hypothesised that inhibiting NF-κB activation would mediate the negative effects of IL-1β on equine tendon cells in 3-dimensional (3D) cultures.

Methods and results:

Here, we tested three inhibitors of NF-κB signalling (Bortezomib, BAY11-7082 and Wedelolactone) along withTJ-M2010-5, an inhibitor of MyD88, which is a critical adaptor protein for mediating IL-1β signalling. None of these inhibitors were able to rescue gel contraction by equine tenocytes exposed to IL-1β in 3D culture. However, the daily application of the interleukin-1 receptor-associated kinase (IRAK)−4 inhibitor PF-06650833 resulted in a partial rescue of collagen contraction and interleukin-6 (IL-6) production by equine tenocytes in 3D culture. Global gene expression using RNA sequencing also revealed a partial rescue, although this was not as complete as that achieved using interleukin-1 receptor antagonist protein (IL1Ra), with many inflammatory pathways remaining upregulated. ENPP2 expression was significantly increased by IL-1β and rescued by both IL1Ra and PF-06650833 suggesting ENPP2 may be involved in collagen contraction. However, direct ENPP2 inhibition does not rescue IL-1β mediated inhibition of contraction and ENPP2 inhibition alone reduces collagen contraction.

Conclusions:

Together, this data demonstrates that IL-1β has a broad mechanism of action on tendon cells which cannot be fully mediated by targeting specific parts of the signalling pathway.

585

News (Medical) associated with Bortezomib

10 Mar 2026

·www.prnewswire.com

Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line

Approval based on unprecedented Phase 3 data demonstrating statistically significant improvements in progression–free survival and overall survival versus standard of care regimens 83.3% of patients were alive at three years, indicating durable clinical benefit March 5, 2026 -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.1 TECVAYLI® and DARZALEX FASPRO® work synergistically to prime and activate the immune system to eradicate myeloma cells that express the BCMA protein.1 This approval offers a potential new standard of care (SOC) as early as second line and brings a novel treatment approach for the 40% of patients with multiple myeloma who experience disease relapse.2 "This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile," said Dr. Luciano J. Costa, Professor of Multiple Myeloma and Director of the Multiple Myeloma Research and Treatment Program at the University of Alabama at Birmingham, and Primary Investigator of MajesTEC-3*. "The option to use this regimen as early as second line is particularly important because patients with RRMM often experience multiple relapses and reduced responsiveness to therapy over time, which makes earlier treatment with the most effective therapies critical. In addition, the steroid-sparing approach may reduce toxicity and improve tolerability." "There is a critical need to expand community-based treatment options for multiple myeloma patients, allowing them to receive care closer to home while respecting their individual treatment preferences," said Heather Ortner Cooper, President & CEO of the International Myeloma Foundation**. "This approval enhances the therapeutic landscape, giving oncologists diverse options to personalize treatment plans for each patient." "As the leader in hematology, we have a proud history of transforming the treatment landscape for multiple myeloma. This approval represents another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings," said Imran Khan, M.D., Ph.D., Vice President, U.S. Hematology Medical Affairs, Johnson & Johnson. "The FDA approval of TECVAYLI plus DARZALEX FASPRO adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease." The approval is based on data from the Phase 3 MajesTEC-3 study, an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with RRMM who have received at least one prior line of therapy. TECVAYLI® in combination with DARZALEX FASPRO® demonstrated statistically significant improvements in PFS and OS in patients with RRMM compared to standard treatment after a median follow-up of three years in patients with RRMM. Results show an 83% reduction in the risk of disease progression or death compared to standard regimens (hazard ratio [HR], 0.17; 95 percent confidence interval [CI], 0.12-0.23; P3 The three-year PFS rate was 83% compared to 30% in the control arm, underscoring a durable benefit.3 The results were presented in December 2025 as a late-breaking oral presentation at the American Society of Hematology (ASH) Annual Meeting with simultaneous publication in The New England Journal of Medicine. Significant improvements compared to SOC were observed across key secondary endpoints, including treatment response rates, minimal residual disease (MRD)-negativity, OS, and time to worsening of symptoms – revealing the impact of the regimen across varied patient measures.3 TECVAYLI® plus DARZALEX FASPRO® showed higher rates of overall response (ORR) (89.0% vs. 75.3%; OR, 2.65; 95% CI, 1.68-4.18), complete response (≥CR) (81.8% vs. 32.1%; odds ratio [OR], 9.56; 95% CI, 6.47-14.14), and MRD-negativity (58.4% vs. 17.1%; OR, 6.78; 95% CI, 4.53-10.15, P3 OS favored TECVAYLI® plus DARZALEX FASPRO® (HR, 0.46; 95% CI, 0.32-0.65; P® plus DARZALEX FASPRO® arm and the control arm, respectively.3 In the MajesTEC-3 study, TECVAYLI® plus DARZALEX FASPRO® and SOC comparators had similar rates of Grade 3/4 (95.1% vs. 96.6%) treatment-emergent adverse events (TEAE).3 Most Grade 3/4 events were due to cytopenias and infection.3 Infections were observed with TECVAYLI® and DARZALEX FASPRO® (any grade, 96.5%; Grade 3/4, 54.1%) and DPd/DVd control (any grade 84.1%; Grade 3/4 43.4%). Grade 3 or higher infections with TECVAYLI® and DARZALEX FASPRO® declined after the first 6 months of treatment consistent with use of established immunoglobulin supplementation and infection prophylaxis protocols, along with switch to monthly dosing.3 Cytokine release syndrome occurred in 60.1% of patients; all cases were Grade 1/2, did not lead to treatment discontinuation and were effectively managed using standard guidelines.3 Immune effector cell-associated neurotoxicity syndrome was rare and occurred in 1.1% of patients.3 Serious adverse events occurred in 70.7% of patients compared to 62.4% of patients treated with the control regimen, while treatment discontinuations due to adverse events were low (4.6% vs. 5.5%).3 Grade 5 TEAEs were 7.1% and 5.9% with TECVAYLI® plus DARZALEX FASPRO® and DPd/DVd control, respectively.3 The FDA proactively selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) to participate in the Commissioner's National Priority Voucher (CNPV) Pilot Program as it aligns with the program's priority to deliver more innovative therapies for American people. The FDA also granted the application Breakthrough Therapy Designation and Real-Time Oncology Review. Johnson & Johnson offers comprehensive access and support information and resources to assist patients in gaining access to our multiple myeloma therapies. Our patient support program, TECVAYLI® withMe‡, is available to provide personalized support to help patients start and stay on their Johnson & Johnson medicines once the clinical decision has been made to prescribe. TECVAYLI® withMe helps providers support their patients by verifying patients' insurance coverage, providing information on Prior Authorization and Appeals processes and educating on reimbursement processes. Patients can connect to TECVAYLI® withMe to receive cost support, regardless of insurance type, free, personalized one-on-one support from a Care Navigator, and resources and community connections. Learn more at TECVAYLI.com or by calling 833-JNJ-wMe1 (833-565-9631). MajesTEC-3 is an ongoing, Phase 3 randomized study evaluating the safety and efficacy of teclistamab plus daratumumab versus investigator's choice of daratumumab and dexamethasone with either pomalidomide or bortezomib in patients with relapsed/refractory multiple myeloma who have received at least one prior line of therapy. The primary endpoint is PFS and secondary endpoints include complete response or better, overall response rate, minimal residual disease negativity, overall survival, time to worsening of symptoms (MySIm-Q), and safety. The MajesTEC-3 study is a part of the MajesTEC clinical program, which includes exploring the potential of TECVAYLI® as a combination regimen.4 It is the first randomized Phase 3 trial using a bispecific antibody in relapsed/refractory multiple myeloma and confirmatory trial after the initial FDA approval. TECVAYLI® (teclistamab-cqyv) is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. TECVAYLI® received accelerated approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.5 In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months. Since FDA approval, more than 23,000 patients have been treated worldwide with TECVAYLI®. The European Commission (EC) granted TECVAYLI® conditional marketing authorization in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy. In August 2023, the EC granted the approval of a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients who have achieved a complete response or better for a minimum of six months. DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for 11 indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.6 It is the only subcutaneous CD38-directed antibody approved to treat patients with multiple myeloma. DARZALEX FASPRO® is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology. DARZALEX® (daratumumab) received U.S. FDA approval in November 2015 and is approved in eight indications, three of which are in the frontline setting, including newly diagnosed patients who are transplant-eligible and ineligible.7 In 2025, DARZALEX FASPRO® was approved by the U.S. FDA and EMA as the first and only treatment for patients with high-risk smoldering multiple myeloma. DARZALEX® is the first CD38-directed antibody approved to treat multiple myeloma.6 DARZALEX®-based regimens have been used in the treatment of more than 618,000 patients worldwide and more than 68,000 patients in the U.S. alone. In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen Biotech, Inc. an exclusive license to develop, manufacture and commercialize daratumumab. Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.8 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.9 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.10 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S. and more than 12,000 people would die from the disease.11 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.12 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.13,14 INDICATIONS AND USAGE TECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma: References 1 TECVAYLI® U.S. Prescribing Information. 2 Kumar, S. K., et al. (2021). Prognostic factors for early (2 years) relapse after initial therapy in multiple myeloma. Blood, 138(Supplement 1), 3761. https://doi.org/10.1182/blood-2021-151249 3 Maria-Victoria Mateos, et. al., Phase 3 Randomized Study of Teclistamab Plus Daratumumab Versus Investigator's Choice of Daratumumab and Dexamethasone With Either Pomalidomide or Bortezomib (DPd/DVd) in Patients With Relapsed Refractory Multiple Myeloma (RRMM): Results of MajesTEC-3, 2025 American Society of Hematology Annual Meeting. Accessed December 2025. 4 MajesTEC-3, NCT05083169. A Phase 3 Randomized Study Comparing Teclistamab + Subcutaneous Daratumumab (Tec-Dara) Versus Daratumumab SC + Pomalidomide + Dexamethasone (DPd) or Daratumumab SC + Bortezomib + Dexamethasone (DVd). https://clinicaltrials.gov/study/NCT05083169. Accessed December 2025. 5 U.S. FDA Approves TECVAYLI® (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. https://www.jnj.com/u-s-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma. Accessed December 2025. 6 DARZALEX FASPRO® U.S. Prescribing Information. 7 DARZALEX® U.S. Prescribing Information. 8 Rajkumar SV. Multiple Myeloma: 2020 Update on Diagnosis, Risk-Stratification and Management. Am J Hematol. 2020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178. 9 National Cancer Institute. Plasma cell neoplasms. National Institutes of Health. https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq. Accessed October 2025. 10 City of Hope. Multiple myeloma: Causes, symptoms & treatments. https://www.cancercenter.com/cancer-types/multiple-myeloma. Accessed December 2025. 11 American Cancer Society. Myeloma cancer statistics. https://cancerstatisticscenter.cancer.org/types/myeloma. Accessed December 2025. 12 SEER Explorer: An interactive website for SEER cancer statistics [Internet]. Surveillance Research Program, National Cancer Institute. https://seer.cancer.gov/explorer/. Accessed December 2025. 13 American Cancer Society. What is multiple myeloma? https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed December 2025. 14 American Cancer Society. Multiple myeloma early detection, diagnosis, and staging. https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/detection.html. Accessed December 2025. The content above comes from the network. if any infringement, please contact us to modify.

$Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line$

Clinical ResultDrug ApprovalASHBreakthrough Therapy

10 Mar 2026

·www.biospace.com

TECVAYLI®▼ (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy

Application supported by Phase 3 data reinforcing teclistamab regimens as a potential standard of care after at least one prior therapy 1 Teclistamab monotherapy delivered superior progression-free survival and overall survival versus standard of care, reducing the risk of disease progression or death by 71% in a high unmet need patient population 2 BEERSE, BELGIUM, March 10, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced the submission of a Type II variation application to the European Medicines Agency (EMA) seeking approval for an indication extension of TECVAYLI ® ▼(teclistamab) as monotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy. Bringing new hope to a high unmet need population Despite major advances in frontline multiple myeloma treatment, including anti-CD38-based quadruplet regimens, most patients will ultimately relapse. 2 Outcomes are particularly poor once patients become refractory to key backbone therapies such as anti‑CD38 monoclonal antibodies and lenalidomide. 2,3 This patient population has historically faced limited choices and challenging second-line treatment pathways, reinforcing the need for additional effective immunotherapy options that can be given across practice settings. 3 “A significant number of patients with multiple myeloma continue to relapse and become refractory to currently available therapies, representing one of the largest and most challenging unmet needs in the disease,” said Ester in ’t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. “Making teclistamab monotherapy available to patients as early as second line, where it has the potential to meaningfully improve long-term outcomes and change the course of the disease, could bring new hope to patients and their families.” MajesTEC-9 study results The submission is supported by data from the Phase 3 MajesTEC-9 trial evaluating the efficacy and safety of teclistamab versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in 614 patients with RRMM. 1 Results show teclistamab delivers superior progression-free survival (PFS) and overall survival (OS) versus standard of care as early as second line, including a 71% reduction in the risk of disease progression or death (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.23-0.38) and a 40% reduction in the risk of death (HR, 0.60; 95% CI, 0.43-0.83) in a patient population that was predominantly refractory to anti-CD38 monoclonal antibodies and lenalidomide. 2 The safety pro teclistamab monotherapy was clinically manageable and consistent with its known profile, with no new safety signals identified. 2 Infections can be managed with robust infection management protocols, which include patient monitoring, immunoglobulin therapy and antimicrobial prophylaxis. 4 The Independent Data Monitoring Committee recommended unblinding the study based on the strength of the data in the first pre-specified interim analysis. 2 This submission represents the first of several planned global regulatory filings, with full results to be presented at a future major medical meeting. “At Johnson & Johnson, we are driven by a clear purpose to deliver innovations that redefine expectations of what a multiple myeloma diagnosis means to patients, at every stage of the disease,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson. “With today’s regulatory milestone for teclistamab, we are advancing a widely available immunotherapy approach with the potential to support deep and sustained responses over time.” About the MajesTEC-9 study MajesTEC-9 (NCT05572515) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab as a monotherapy versus pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. 1 The majority of patients enrolled were refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%) and more than 90% were refractory to their last line of therapy. 2 The primary endpoints are progression-free survival (PFS) and the number of participants reporting cytokine release syndrome (CRS) cases by severity. 1 Secondary endpoints include complete response or better (≥CR); duration of response (DOR); time to next treatment (TTNT); progression-free survival on next-line therapy (PFS2); overall survival (OS); number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity; change from baseline in symptoms, functioning and overall health-related quality of life (HRQoL) as assessed by the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30); and time to worsening in symptoms, functioning and overall HRQoL. 1 The MajesTEC-9 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen. 1 About Teclistamab Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. 5 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. 6 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody. 4,7 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer. Teclistamab is currently being evaluated in several combination studies. 4,8,9,10,11 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: . ▼ In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. 6 About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 12 ,13 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 12,13 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 14 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter. 15 ,16,17 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 18 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Cautions Concerning Forward-Looking Statements This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. END Key Search Terms MajesTEC-9 Phase 3 clinical trial TECVAYLI Teclistamab Teclistamab monotherapy Relapsed and or refractory multiple myeloma (RRMM) Early relapse multiple myeloma Second-line multiple myeloma treatment First relapse therapy for multiple myeloma Treatment resistance in multiple myeloma Progression-free survival (PFS) in multiple myeloma Overall survival (OS) in multiple myeloma Multiple myeloma Bispecific antibody therapy BCMA-targeted bispecific therapy EMEA haematology pipeline Multiple myeloma innovation Multiple myeloma treatment [1] ClinicalTrials.gov. A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-9). Available at: . Last accessed: March 2026. [2] Johnson & Johnson.com. TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide. Available at: . Last accessed: March 2026. [3] Ramasamy K, et. al. Real-World Treatment Patterns and Clinical Outcomes in Patients With Multiple Myeloma Previously Treated With Lenalidomide and an Anti-CD38 Monoclonal Antibody. Clin Lymphoma Myeloma Leuk. 2025 May;25(5):337-348.e2. [4] European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: . Last accessed: March 2026. [5] Johnson & Johnson.com. Janssen Marks First Approval Worldwide for TECVAYLI®▼(teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma. Available at: . Last accessed: March 2026. [6] Johnson & Johnson.com. European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: . Last accessed: March 2026. [7] Moreau P, et al. Teclistamab in Relapsed or Refractory Multiple Myeloma. New England Journal of Medicine. 2022;287(6):494-505. [8] ClinicalTrials.gov. A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: . Last accessed: March 2026. [9] ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: . Last accessed: March 2026. [10] ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: . Last accessed: March 2026. [11] ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: . Last accessed: March 2026. [12] Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207. [13] American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: . Last accessed: March 2026. [14] ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: $0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27 . Last accessed: March 2026. [15] Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. [16] Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. [17] Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. [18] American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: March 2026. CONTACT: Media contact: Jenni Mildon jmildon@its.jnj.com +44 7920 418 552 Investor contact: Jessica Margevich investor-relations@its.jnj.com

Phase 3Clinical ResultDrug ApprovalImmunotherapyASCO

06 Mar 2026

·www.fiercepharma.com

J&J's Tecvayli-Darzalex multiple myeloma combo takes home FDA's 3rd national priority nod

The FDA converted its accelerated approval for Johnson & Johnson's Tecvayli into a traditional approval based on a phase 3 combo study. Johnson & Johnson’s standout trial results for its Tecvayli and Darzalex Faspro pairing in previously treated relapsed or refractory multiple myeloma have earned the company the third ultra-speedy approval awarded under the FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program. On top of the combo nod, which specifically covers patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, the FDA also threw in a bonus label update for Tecvayli by converting the accelerated approval it won in 2022 to a traditional approval.The agency considered J&J’s phase 3 MajesTEC-3 study solid enough confirmatory evidence to support Tecvayli’s full approval as a monotherapy as well, it explained in a release. “Multiple myeloma is notoriously challenging to treat,” FDA Commissioner Marty Makary, M.D., said in the release. “When we saw the most impressive second-line myeloma trial results in history, we acted quickly to bring this finding to everyday Americans wrestling with the disease.”J&J unveiled what it described as “unprecedented” MajesTEC-3 study results in December at the 2025 American Society of Hematology annual meeting. Soon after, FDA leaders got in touch with J&J about doling out the CNPV. “When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly,” Makary said at the time. In the study, the pairing of Tecvayli and subcutaneous Darzalex delivered an 83% reduction in the risk of disease progression or death compared to standard regimens, including Darzalex and dexamethasone with either Bristol Myers Squibb’s Pomalyst or Takeda’s Velcade, at nearly three years of follow-up. More than 90% of patients who were progression-free at six months remained that way at three years, while overall survival rates came out to 83.3% for Tecvayli-Darzalex compared to 65% in the control arm. With the results, J&J quickly submitted a supplemental drug application to the FDA under the agency’s Real-Time Oncology Review program, a framework that allows the agency to evaluate the data before the full application is formally submitted, it said at the time. As for the CNPV pathway, the initiative launched last June and aims to cut drug review timelines from six months or longer down to one or two months for medicines that align with U.S. national priorities. In J&J’s case, the company had formally filed its approval bid 55 days prior to its March 5 nod, according to the FDA. This is the same review pathway the FDA used for last week’s CNPV nod, which went to Boehringer Ingelheim’s lung cancer treatment Hernexeos. Before the quick succession of oncology CNPV approvals, the first nod under the new program went to USAntibiotics in December. “The FDA is now proactively moving to cut idle time to accelerate meaningful treatments for the American people,” Makary said in the latest approval announcement. Not all companies have been successful with the new regulatory pathway. Last month, Disc Medicine received an FDA rejection for its rare blood disease candidate, leading to commercial team layoffs this week. J&J, for its part, sees the approval as “another pivotal milestone in improving outcomes for patients living with this disease, with a unique regimen accessible to patients across all practice settings,” the company’s vice president of U.S. hematology medical affairs, Imran Khan, M.D., Ph.D., said in a release. “The FDA approval of Tecvayli plus Darzalex Faspro adds a powerful new treatment option to our multiple myeloma portfolio, moving us closer to our ambition of one day curing this disease,” Khan added.While multiple myeloma bispecific Tecvayli and star CD38 antibody Darzalex could put pressure on CAR T-cell therapies including J&J’s own Carvykti, the company sees the combo as a way to offer an equally efficacious therapy to community doctors who can’t refer patients to the CAR-T treatments, Khan told Fierce Pharma in a December interview.

Clinical ResultPhase 3Drug ApprovalASHImmunotherapy

100 Deals associated with Bortezomib

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KEGG	Wiki	ATC	Drug Bank
D03150	Bortezomib	L01XX32	DB00188

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	Japan	Janssen Pharmaceutical KK	20 Oct 2006
Waldenstrom Macroglobulinemia	Japan	Janssen Pharmaceutical KK	20 Oct 2006
Mantle-Cell Lymphoma	European Union	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	Iceland	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	Liechtenstein	Janssen-Cilag International NV	26 Apr 2004
Mantle-Cell Lymphoma	Norway	Janssen-Cilag International NV	26 Apr 2004
Multiple Myeloma	United States	Takeda Pharmaceuticals U.S.A., Inc.	13 May 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hematologic Neoplasms	Phase 3	Finland	Celgene Corp.	18 Mar 2015
Diffuse large B-cell lymphoma recurrent	Phase 3	Italy	Janssen-Cilag Ltd.	04 Feb 2013
Diffuse large B-cell lymphoma recurrent	Phase 3	Italy	Janssen Pharmaceutica NV	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	Italy	Janssen-Cilag Ltd.	04 Feb 2013
Diffuse large B-cell lymphoma refractory	Phase 3	Italy	Janssen Pharmaceutica NV	04 Feb 2013
Plasma Cell Leukemia	Phase 3	China	Janssen Scientific Affairs LLC	13 Jan 2012
Plasma Cell Leukemia	Phase 3	Australia	Janssen Scientific Affairs LLC	13 Jan 2012
Plasma Cell Leukemia	Phase 3	South Korea	Janssen Scientific Affairs LLC	13 Jan 2012
Diffuse Large B-Cell Lymphoma	Phase 3	Switzerland	Janssen-Cilag Ltd.	01 Apr 2011
Diffuse Large B-Cell Lymphoma	Phase 3	United Kingdom	Janssen-Cilag Ltd.	01 Apr 2011

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01919086 (CTgov)	Phase 2	Multiple Myeloma	30	Lenalidomide+Bortezomib+Dexamethasone	boaurcrgsz = meeivukoit llidyzavwu (hikmdfpmuz, hgognuoogt - qhgqbrlhvo) View more	-	02 Mar 2026
NCT02553460 (Pubmed \| Lancet Haematol)	Phase 1/2	Acute Lymphoblastic Leukemia KMT2A rearranged	50	BortezomibDexamethasoneVorinostatMitoxantronePegaspargase + BortezomibDexamethasoneVorinostatMitoxantronePegaspargase + BortezomibDexamethasoneVorinostatMitoxantronePegaspargasee + BortezomibDexamethasoneVorinostatMitoxantronePegaspargase + BortezomibDexamethasoneVorinostatMitoxantronePegaspargase	xmlbjspoko(ufymxuzgkt) = wqpagcdzyh hsrbrhkqtb (egbkztcadt )	Positive	01 Mar 2026
NCT03850366 (Tandem Meetings ASTCT and CIBMTR2026)	Phase 2	Peripheral Stem Cell Transplantation	9	Fludarabine+Melphalan+TBI200 cGy+Haplo-SCT+PTCY+Bortezomib (Hematologic Malignancies)	tyyvqutsik(widzcsatqi) = Six patients had cytokine release syndrome (CRS) with ASTCT grade of 1. Four patients had neutropenic fever, and one patient had engraftment fever. Median neutrophils and platelets engraftment were 16 and 26 days respectively. Two patients had reactivation of CMV, 2 had EBV, one had adenovirus, 3 had HHV6, all resolved. At 1 year for 7 evaluable patients IgG were >400 mg/dl and CD4 > 200 cells/ul. nopyzydcqm (uzyniakmkh ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Phase 1/2	Graft vs Host Disease	57	Post-transplant cyclophosphamide 50mg/kg (Full dose PTC)	pthgxqwmkh(ucdswtdqog) = 1 patient developed PTLD, responsive to rituximab ovboiapavs (voozihgtdy ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Phase 1/2	Graft vs Host Disease	57	Post-transplant cyclophosphamide 37.5mg/kg (Reduced dose PTC)		Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	140	Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells <5×10^6/kg)	csbajxqqdb(objgheqxqx) = bbdwcgvcjk ewrkwnevcl (nbkywxlcai ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	140	Daratumumab+ bortezomib/cafilzomib+ lenalidomide+ dexamethasone (CD34+ cells ≥5×10^6/kg)	csbajxqqdb(objgheqxqx) = jblzakditr ewrkwnevcl (nbkywxlcai ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	71	Daratumumab+Bortezomib+Lenalidomide+Dexamethasone	auzraysjsl(zmfkcnyptj) = gmycinxnlr ykccpvqtew (kgarqpeafv ) View more	Positive	04 Feb 2026
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Multiple Myeloma	71	Daratumumab+Bortezomib+Lenalidomide+Dexamethasone (2025 IMS/IMWG high-risk criteria)	auzraysjsl(zmfkcnyptj) = urglfoarra ykccpvqtew (kgarqpeafv ) View more	Positive	04 Feb 2026
ASH2025	Not Applicable	Immunoglobulin Light-Chain Amyloidosis	95	Daratumumab+CyBorD	svrbvjlifj(hifhsjgqza) = zywuouuvtd tuigxitber (cjnogfyckj ) View more	Positive	06 Dec 2025
NCT04474938 (ASH2025)	Phase 2	Immunoglobulin Light-Chain Amyloidosis	40	Daratumumab + Bortezomib + Dexamethasone	jahqeikdcr(zngfvpsyld) = jotkfxjwlf nqbwnibbhn (xgrequhcqm, 36.3 - 68.7) View more	Positive	06 Dec 2025
ECWM-1 (ASH2025)	Not Applicable	Waldenstrom Macroglobulinemia First line	204	Bortezomib + Dexamethasone + Rituximab + Cyclophosphamide	rswgnvabav(dbdjpbqdvr) = Grade≥3 toxicities were mainly hematological rsvgottsyx (xztwsqnodn ) View more	Positive	06 Dec 2025
ECWM-1 (ASH2025)	Not Applicable	Waldenstrom Macroglobulinemia First line	204	Dexamethasone + Rituximab + Cyclophosphamide		Positive	06 Dec 2025
ASH2025	Phase 2	Multiple Myeloma	51	isatuximab+bortezomib+lenalidomide+dexamethasone (multiple myeloma + newly diagnosed)	xzspchgmzy(fyorcancmb) = zggossmdkh wjizkfrwyy (mjftpyyofk ) View more	Positive	06 Dec 2025

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