CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

NeoplasmsImmune System DiseasesNervous System Diseases+ [3]

Active Indication-

Inactive Indication

Aggressive B-Cell Non-Hodgkin LymphomaAnaplastic Large-Cell LymphomaB-cell lymphoma refractory+ [13]

Originator Organization

Immunomedics, Inc.

Active Organization-

Inactive Organization

Takeda Pharmaceutical Co., Ltd.

Immunomedics, Inc.

Gilead Sciences, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

RegulationOrphan Drug (US)

Gene Sequence

Sequence Code 52152L

Source: *****

Sequence Code 10069122H

Source: *****

Clinical Trials associated with Veltuzumab

IRCT20160422027520N11 / SuspendedPhase 2/3IIT

Effects of Anti-CD20 monoclonal antibody on immunologic factors in elderly patients with ischemic stroke

Start Date20 May 2019

Sponsor / Collaborator

Tabriz University of Medical Sciences

NCT01390545 / TerminatedPhase 2

VELVET (Veltuzumab Various Doses Exploratory Trial), a Randomized, Double Blind, Placebo Controlled, Multicentre, Multinational Phase II Dose Range Finding Trial in Subjects With Moderate to Severe Rheumatoid Arthritis Insufficiently Controlled With Either Methotrexate Alone or Methotrexate Plus Anti-tumour Necrosis Factor Biological Treatment, Comparing 3 Different Subcutaneous Dosages of Anti-CD20 Monoclonal Antibody Veltuzumab to Placebo as an add-on Therapy to Methotrexate.

This is a multi-national, multi-centre, placebo-controlled, double-blind, randomized, 4-arm parallel group trial, comparing three different dose levels (80 mg, 160 mg and 320 mg) of veltuzumab to placebo, administered weekly (days 1, 8, 15 and 22) by subcutaneous (sc) injection to subjects with moderate to severe rheumatoid arthritis (RA) (cumulative veltuzumab doses 320 mg, 640 mg, and 1280 mg, respectively). All subjects will be on continued stable co-medication with methotrexate (MTX).

Start Date01 Aug 2011

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

NCT01147393 / TerminatedPhase 1/2IIT

Phase I/II Study of Combination Veltuzumab (Anti-CD20) and Fractionated 90Y- Epratuzumab (Anti-CD22) Radioimmunotherapy in Patients With Follicular Lymphoma

A Phase I/II clinical trial using a fractionated dosing regimen of 90Y-epratuzumab (anti-CD22) has showed encouraging responses in follicular and aggressive NHL with an ability to administer safely 2 injections of 20 mCi/m2 spaced 1 week apart. The investigators propose to combine this active 90Y-epratuzumab treatment with a regimen of veltuzumab that was also found active in Phase I/II trials.
The goal of this study is to determine the safety and efficacy of 90Y-epratuzumab when used in combination with veltuzumab. The primary objective is to determine the response rate of this combination treatment. Secondary objectives are to assess safety, pharmacokinetics and targeting of 90Y-epratuzumab . Veltuzumab blood levels and anti-antibody responses will also be monitored at various times.

Start Date01 Oct 2010

Sponsor / Collaborator

Weill Medical College of Cornell University

[+1]

100 Clinical Results associated with Veltuzumab

100 Translational Medicine associated with Veltuzumab

100 Patents (Medical) associated with Veltuzumab

1,781

Literatures (Medical) associated with Veltuzumab

01 Feb 2025·Neurology-Clinical Practice

Impact of Continuous Ofatumumab Exposure During Pregnancy in Multiple Sclerosis

Article

Author: Moser, Tobias ; Otto, Ferdinand ; Hellwig, Kerstin ; Hefner, Simon ; Casaccia, Tiago Lerda ; Hofstaetter, Edda

Objectives:

Anti-CD20 therapies are highly effective treatment options for patients with multiple sclerosis (MS), an inflammatory disorder of the CNS commonly affecting women of childbearing age. Anti-CD20 therapies are however unlicensed for use in pregnancy. Belonging to the IgG1 family, anti-CD20 monoclonal antibodies are likely to cross the placenta, especially after the 20th week of gestation. Our objective was to analyze the impact of ofatumumab (OFA), a subcutaneous anti-CD20 monoclonal antibody, during pregnancy.

Methods:

We present the case of a woman with MS who accidentally administered OFA every 4 weeks until delivery. In addition to detailing the clinical and laboratory outcomes of both mother and child, we provide a summary of the available evidence regarding anti-CD20 treatment during pregnancy and breastfeeding.

Results:

Our patient gave birth to a healthy girl between estimated gestational weeks 32-35. Notably, at 3 months postpartum and 4 months after the last OFA administration, the mother remained fully B-cell depleted while the B-cell counts of the child were within the normal range.

Discussion:

Further data are necessary to confirm that OFA treatment during pregnancy does not affect neonatal B cells.

01 Dec 2024·JOURNAL OF DERMATOLOGY

Case report: A novel high‐dose intravenous immunoglobulin preparation for the treatment of severe pemphigus vulgaris failing standard therapy

Article

Author: Mihalceanu, Silvia ; Wiedenmayer, Nadine ; Enk, Alexander H. ; Hogrefe, Katharina ; Winkler, Julia K.

Abstract:

Pemphigus vulgaris (PV) is a severe autoimmune bullous dermatosis that is characterized by autoantibodies against epidermal adhesion proteins causing painful mucosal and skin blistering. Standard treatments for PV include corticosteroids, steroid‐sparing immunosuppressants, or intravenous monoclonal anti–CD20‐antibody therapy. The European guidelines suggest high‐dose intravenous immunoglobulin (IVIg) therapy as a promising approach for severe or treatment‐resistant cases. We report on a 65‐year‐old woman with severe and recurrent disease who achieved long‐term disease stabilization with IVIg treatment. Because of recurrent fatigue and headache, the patient was switched to an alternative IVIg preparation with a novel manufacturing process, thus ensuring high purity and better tolerability. We observed excellent efficacy, yet side effects remained largely unchanged. Further studies are necessary to evaluate the long‐term efficacy and tolerability of this new IVIg preparation.

01 Nov 2024·Clinical Kidney Journal

Obinutuzumab treatment for membranous nephropathy: effectiveness and safety concerns during the COVID-19 pandemic

Article

Author: Wang, Yifeng ; Hao, Chuan-Ming ; Zhao, Wenqian ; Liu, Shaojun ; Xie, Qionghong ; Chen, Ruiying ; Xu, Mingyue ; Huang, Xiaoyun ; Zhang, Hanzhen ; Xu, Yunyu ; Zhang, Min

ABSTRACT:

Background:

Obinutuzumab is a humanized and glycoengineered anti-CD20 monoclonal antibody that has been shown to induce more profound B-cell depletion than rituximab. The effectiveness and safety of obinutuzumab in the treatment of membranous nephropathy remain unclear.

Methods:

This was a retrospective study conducted in Huashan Hospital, Fudan University between 1 December 2021 and 30 November 2023. Patients with membranous nephropathy were included to assess the effectiveness and safety of obinutuzumab and prevalence of severe pneumonia during the outbreak of COVID-19 in China.

Results:

Eighteen patients were included in the study assessing the effectiveness of obinutuzumab. After a 12-month follow-up, 14 patients (78%) achieved remission, with six (33%) achieving complete remission and eight (44%) achieving partial remission. Among the 18 obinutuzumab-treated patients contracting COVID-19 for the first time, six (33%) developed severe pneumonia, and one died. By contrast, two of the 37 patients receiving glucocorticoids combined with cyclophosphamide, and none of the 44 patients on calcineurin inhibitors or the 46 patients on rituximab developed severe pneumonia. However, compared to patients receiving rituximab or glucocorticoids plus cyclophosphamide, the obinutuzumab-treated patients had a longer duration of membranous nephropathy and immunosuppressive therapy. Therefore, cardinal matching was employed to balance these baseline characteristics. Owing to small sample size for each regimen, patients receiving all the three non-obinutuzumab immunosuppressive regimens were grouped as a control cohort. After matching for age, gender, remission status, duration of membranous nephropathy, duration of immunosuppressive therapy, and ongoing immunosuppression, the obinutuzumab-treated patients still had a significantly higher incidence of severe pneumonia compared to those on other regimens (P = .019).

Conclusion:

Obinutuzumab was an effective treatment option for patients with membranous nephropathy. On the other hand, it was associated with a higher incidence of severe pneumonia following COVID-19 infection compared to other immunosuppressive regimens.

News (Medical) associated with Veltuzumab

18 Sep 2024

·www.novartis.com

New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients

Nearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study1 More than 80% of patients receiving first-line Kesimpta were progression-free for up to six years, reinforcing the value of introducing Kesimpta early1 Patients switching to Kesimpta from IV anti-CD20 therapy showed no new active lesions (Gd+ T1) 12 months after switch in separate US single-arm, open-label, Phase IIIb OLIKOS study2 Basel, September 18, 2024 – Novartis today announced new data from the ALITHIOS open-label extension study. Data show first-line Kesimpta® (ofatumumab) treatment for up to six years led to less disability and disease progression in recently diagnosed (≤3 years) and treatment-naïve (RDTN) people with relapsing multiple sclerosis (RMS), compared to those who switched from teriflunomide1. A separate US-based single-arm OLIKOS Phase IIIb study showed that at 12 months, all clinically stable RMS patients who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing (Gd+) T1 lesions, a commonly used marker of disease activity, compared to baseline2. These data will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting in Copenhagen, Denmark on September 18-20. “We continue to study the efficacy and safety of Kesimpta in different populations of people living with relapsing multiple sclerosis as part of our mission to advance care,” said Norman Putzki, M.D., Ph.D., Global Development Unit Head, Neuroscience & Gene Therapy, Novartis International AG. “Novartis is committed to understanding and solving some of the most burdensome neurological conditions to improve the quality of life for patients and their caregivers, and to make a positive impact on society.” Kesimpta benefits in first-line patients Data from the overall ALITHIOS study population showed that continuous use of Kesimpta was associated with numerically fewer 6-month confirmed disability worsening (6mCDW) and progression independent of relapse activity (6mPIRA) events up to six years compared to those who switched from teriflunomide1. These benefits appeared more pronounced in the RDTN subgroup, defined as starting treatment within three years of diagnosis1. RDTN patients receiving continuous Kesimpta were more likely to remain free from 6mCDW compared to those who switched to Kesimpta from teriflunomide (83.4% vs. 76.3%)1. RDTN patients receiving continuous Kesimpta were also more likely to be free of 6mPIRA vs. switching from teriflunomide (88.9% vs. 83.3%)1. “These data showed that people recently diagnosed with relapsing multiple sclerosis who received first-line Kesimpta had fewer disability worsening events and greater likelihood of being progression-free,” said lead investigator Amit Bar-Or, M.D., Director of the Center for Neuroinflammation and Neurotherapeutics at the University of Pennsylvania. “The reduction of disability accumulation observed early in the disease course supports earlier adoption of Kesimpta.” Limitations of the results include a potential for attrition bias and the open-label nature of the extension study1. No new T1 lesions in patients who switched from IV therapy to KesimptaThe US-based OLIKOS study analyzed 102 clinically stable RMS patients who switched from previous IV anti-CD20 therapy (99% from ocrelizumab) to Kesimpta2. For 84 patients with MRI results, no new Gd+ T1 lesions were observed at 12 months, the study’s primary endpoint. Additionally, 98% of patients did not develop new/enlarging T2 (NeT2) lesions at 12 months, an exploratory endpoint in the study2. Treatment-emergent adverse events (TEAEs) occurred at a similar frequency as in the core Phase III ASCLEPIOS clinical trials, with no new safety signals identified2. The most commonly reported (≥10%) TEAEs were COVID-19, headache, fatigue, and urinary tract infection. Mean serum immunoglobulin G (IgG) and IgM levels remained stable up to 12 months2. About Multiple SclerosisMultiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system characterized by myelin destruction and axonal damage in the brain, optic nerves and spinal cord3. MS, which affects nearly 3 million people worldwide4, can be characterized into four main types: clinically isolated syndrome (CIS), relapsing-remitting (RRMS), secondary progressive (SPMS) and primary progressive (PPMS)5. The various forms of MS can be distinguished based on whether a patient experiences relapses (clearly defined acute inflammatory attacks of worsening neurological function), and/or whether they experience progression of neurologic damage and disability from the onset of the disease3. About Kesimpta® (ofatumumab)Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously6-9. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional6,7. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen10. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 201511. Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in over 90 countries worldwide with more than 100,000 patients treated as of August 20246,7,12. Novartis in NeuroscienceAt Novartis, we have been tackling neurological conditions for more than 80 years, launching transformative treatments which have made meaningful differences to millions of people worldwide now and in the future. We continue to collaborate on industry-leading treatments in multiple sclerosis, pediatric neurology, neurodegeneration and neuroinflammation and psychiatry. DisclaimerThis media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise. About NovartisNovartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Bar-Or A, Hauser SL, Cohen JA, et al. Early Initiation of Ofatumumab Delays Disability Progression in People With Relapsing Multiple Sclerosis: 6-Year Results From ALITHIOS Open-Label Extension Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting; September 18–20, 2024; Copenhagen, Denmark. Hua LH, Brown B, Camacho E, et al. Efficacy and Safety in Patients With Relapsing Multiple Sclerosis Who Switched to Subcutaneous Ofatumumab From Intravenous Anti-CD20 Therapies: Results From the OLIKOS Study. Poster presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2024 Annual Meeting; September 18–20, 2024; Copenhagen, Denmark. Guthrie E. Multiple sclerosis: A primer and update. Adv Studies Pharm. 2007;4(11):313-317. Portaccio E, Magyari M, Kubala Havrdova E, et al. Multiple sclerosis: emerging epidemiological trends and redefining the clinical course. Lancet Reg. Health Eur. 2024;44:100977. National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS Accessed September 10, 2024 Kesimpta. Prescribing Information. Novartis Pharmaceuticals Corporation East Hanover. 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125326s079lbl… Accessed September 11, 2024. Kesimpta. Summary of Product Characteristics. Novartis Ireland Limited. 2023. https://www.ema.europa.eu/en/documents/product-information/kesimpta-epar-product-information_en.pdf Accessed June 23, 2024. Hauser SL, Kappos L, Bar-Or A, et al. The Development of Ofatumumab, a Fully Human Anti-CD20 Monoclonal Antibody for Practical Use in Relapsing Multiple Sclerosis Treatment. Neurol Ther. 2023;12(5):1491-1515. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Annual Forum; February 27–29, 2020; West Palm Beach, FL, US. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Annual Meeting 2016; September 14–17, 2016; London, UK. Genmab. Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Available from: https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d Accessed September 10, 2024. Novartis. Data on file. Novartis Media RelationsE-mail: media.relations@novartis.com Central North America Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414 Anna Schäfers +41 79 801 7267 Switzerland Satoshi Sugimoto +41 79 619 2035 Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com Central North America Isabella Zinck +41 61 324 7188 Sloan Simpson +1 862 345 4440 Nicole Zinsli-Somm +41 61 324 3809 Jonathan Graham +1 201 602 9921 Imke Kappes +41 61 324 8269 Parag Mahanti +1 973 876 4912

Clinical ResultPhase 3Drug Approval

27 Aug 2024

·www.prnewswire.com

JW Therapeutics Announces NMPA Approval of the Supplemental Biological License Application for Carteyva® in Adult Patients with Relapsed or Refractory Mantle Cell Lymphoma

SHANGHAI, Aug. 27, 2024 /PRNewswire/ -- JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China has approved the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene autoleucel injection) for the treatment of adult patients with relapsed or refractory Mantle Cell Lymphoma (r/r MCL). This is the third marketing approval on Carteyva® submitted by JW Therapeutics, and is the first cell therapy product approved in China for the treatment of patients with r/r MCL. Carteyva® was granted, by NMPA, Breakthrough Therapy Designation in Mar 2022, as well as Priority Review in Dec 2023. MCL is a heterogeneous B cell non-Hodgkin lymphoma which is currently incurable with existing therapies[1]. MCL, associated with a poor prognosis, mainly occurs in elderly men who were not diagnosed until advanced stage[2]. Significant progress has been made in the last decade as the treatment paradigm has shifted from traditional chemoimmunotherapy toward targeted therapies such as bruton tyrosine kinase inhibitors (BTKi). Despite the use of BTKi in r/r MCL has improved their survival outcomes, many patients will ultimately relapse with shortened remission durations (6~10 months) [3]. Notwithstanding the above, there are still unmet medical needs for a safe, effective novel approach to overcome the limitations of current treatments of r/r MCL. The sBLA was supported by the clinical results from a single-arm, multi-center, pivotal study on Carteyva® in adult patients with r/r MCL in China. In the study, patients with r/r MCL who had been treated with a CD20-targeting antibody, anthracycline or bendamustine, or BTKis were included. After being treated with lymphodepleting chemotherapy, patients received Carteyva® (100×106 CAR+ T cells). As of August 7th, 2023, a total of 59 patients received Carteyva® infusion. Of 59 efficacy evaluable patients, Carteyva® demonstrated remarkable clinical responses achieving high rates of objective response rate (ORR) and complete response rate (CRR) (best ORR 81.36%, best CRR 67.80%) and the incidence of severe (grade ≥ 3) cytokine release syndrome (CRS) was 6.8%, the incidence of severe (grade ≥ 3) neurotoxicity (NT) was 6.8%. Sophia Yang, Senior Vice President and Head of Regulatory, Research & Development of JW Therapeutics, noted: "We are delighted to have a product that can deliver meaningful efficacy in this disease, nearly 70% of patients with r/r MCL have achieved complete remission after treatment with Carteyva®, and the overall safety data demonstrated that the treatment was generally well-tolerated. Carteyva® becomes the first commercial CAR-T cell product for the treatment of r/r MCL in China." References The consensus of the diagnosis and treatment of mantle cell lymphoma in China (2016 version). Chin J Hematol.2016, 37(9):735-741. Herrmann A, Hoster E, Zwingers T, et al. Improvement of Overall Survival in Advanced Stage Mantle Cell Lymphoma[J]. Journal of Clinical Oncology, 2009, 27(4):511-518. Burkart M, Karmali R. Relapsed/Refractory Mantle Cell Lymphoma: Beyond BTK Inhibitors. J Pers Med. 2022 Mar 1;12(3):376. About Relmacabtagene Autoleucel Injection Relmacabtagene autoleucel injection (abbreviated as relma-cel, trade name for oncology indications: Carteyva®) is an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics based on a CAR-T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). Being the first product of JW Therapeutics, Carteyva® has been approved by the China National Medical Products Administration (NMPA) for three indications, including the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBLC) after two or more lines of systemic therapy, the treatment of adult patients with follicular lymphoma that is refractory or that relapses within 24 months of second-line or above systemic treatment (r/r FL), and the treatment of adult patients with relapsed or refractory mantle cell lymphoma ("r/r MCL") after two or more lines of systemic therapy including bruton tyrosine kinase inhibitors ("BTKi"), making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, priority review and breakthrough therapy designations. About JW Therapeutics JW Therapeutics (HKEx:2126) is an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products. Since its founding in 2016, JW Therapeutics has built an integrated platform for product development in cell immunotherapy, as well as a product pipeline covering hematologic malignancies, solid tumors and autoimmune diseases. JW Therapeutics is committed to bringing breakthrough and quality cell immunotherapy products and the hope of a cure to patients in China and beyond, and to leading the healthy and standardized development of China's cell immunotherapy industry. For more information, please visit . Forward-Looking Statements The forward-looking statements are based on the management's expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described. Significant risks and uncertainties, include those discussed below and more fully described in Hong Kong Exchanges and Clearing Limited (HKEx) reports filed by the Company. Unless otherwise noted, the Company is providing this information as of the date it publicized, and expressly disclaims any duty to update information contained in the issues and relevant information, or provide any explanation. For detailed information, please visit the company website: . SOURCE JW Therapeutics

ImmunotherapyDrug ApprovalCell TherapyBreakthrough TherapyPriority Review

09 Aug 2024

·www.fda.gov

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma

On December 22, 2022, the Food and Drug Administration (FDA) granted accelerated approval to mosunetuzumab-axgb (Lunsumio, Genentech, Inc.), a bispecific CD20-directed CD3 T-cell engager for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Mosunetuzumab-axgb was evaluated in GO29781 (NCT02500407), an open-label, multicenter, multi-cohort study. The efficacy population consisted of 90 patients with relapsed or refractory FL who had received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody and an alkylating agent. The main efficacy outcome measure was objective response rate (ORR) assessed by an independent review facility according to standard criteria for non-Hodgkin’s lymphoma (Cheson 2007). The ORR was 80% (95% CI: 70, 88), with 60% achieving complete responses. With a median follow-up of 14.9 months among responders, the estimated median duration of response (DOR) was 22.8 months (95% CI: 10, not reached) and the estimated DOR rate at 12 months and 18 months was 62% and 57%, respectively. The prescribing information has a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS). Warnings and precautions include neurologic toxicity, infections, cytopenias, and tumor flare. Among 218 patients with hematologic malignancies who received mosunetuzumab-axgb at the recommended dose, CRS occurred in 39% of patients, neurologic toxicity in 39% (including ICANS in 1%), serious infections in 17%, and tumor flare in 4%. For CRS, Grade 2 occurred in 15%, Grade 3 in 2%, and Grade 4 in 0.5%. In the pooled safety population of 218 patients, the most common adverse reactions (≥20%) were cytokine release syndrome, fatigue, rash, pyrexia, and headache. The most common Grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocyte count, decreased phosphate, increased glucose, decreased neutrophil count, increased uric acid, decreased white blood cell count, decreased hemoglobin, and decreased platelets. The recommended mosunetuzumab-axgb dose is 1 mg on Cycle 1 Day 1, 2 mg on Cycle 1 Day 8, 60 mg on Cycle 1 Day 15, 60 mg on Cycle 2 Day 1, and 30 mg on Day 1 in subsequent cycles. A treatment cycle is 21 days. Mosunetuzumab-axgb should be administered for 8 cycles unless patients experience unacceptable toxicity or disease progression. After 8 cycles, patients with a complete response should discontinue therapy. Patients with a partial response or stable disease should continue treatment up to 17 cycles unless they experience progressive disease or unacceptable toxicity. View full prescribing information for Lunsumio. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. This application was granted priority review and breakthrough designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. The application also was granted orphan drug designation. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. For information on the COVID-19 pandemic, see the following resources: FDA: Coronavirus Disease 2019 (COVID-19) NCI: Coronavirus: What People With Cancer Should Know CDC: Coronavirus (COVID-19) Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer. Content current as of: 12/23/2022 Regulated Product(s) Drugs 12/23/2022 Drugs Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description

Accelerated ApprovalDrug ApprovalOrphan DrugPriority ReviewBreakthrough Therapy

100 Deals associated with Veltuzumab

External Link

KEGG	Wiki	ATC	Drug Bank
D09031	Veltuzumab	-	DB05656

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	Phase 2	US	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	AR	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	CA	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	CZ	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	DE	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	HU	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	IT	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	MX	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	PL	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011
Neoplasms	Phase 2	ES	Takeda Pharmaceutical Co., Ltd.	01 Aug 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECTRIMS2023	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	-	anti-CD20 monoclonal antibody (Treatment-naïve RRMS)	wdmodlnnza(lsdlwjxudr) = ocdvynuwej oebwnwvyfw (sifwxeypqg )	Positive	30 Sep 2023
				anti-CD20 monoclonal antibody (RRMS treated with ocrelizumab or rituximab for 6 months)	wdmodlnnza(lsdlwjxudr) = thihdorveg oebwnwvyfw (sifwxeypqg )
ECTRIMS2022	Not Applicable	anti-CD20 IgG1 monoclonal antibodies	57	Ocrelizumab 300mg	ygqbifartt(fofcvtiatw) = xpmijikryg uygpjbznfu (zgykqdrycs ) View more	Positive	12 Oct 2022
				Ocrelizumab 600mg	ygqbifartt(fofcvtiatw) = ehzalvslqd uygpjbznfu (zgykqdrycs ) View more
ECTRIMS2022	Not Applicable	Multiple Sclerosis, Relapsing-Remitting CD20	-	Anti-CD20 mAb treated patients with RRMS	wrnyqpgnym(hzusbuyafr) = ipgdxzbhze wbzdpmtmry (tpjuarywap ) View more	-	12 Oct 2022
				anti-CD20 monoclonal antibody (Treatment naïve patients with RRMS)	wrnyqpgnym(hzusbuyafr) = jgfkupbohr wbzdpmtmry (tpjuarywap ) View more
ACTRIMS2020	Not Applicable	-	-	anti-CD20 monoclonal antibody (RT-PCR)	thtuawibpn(ubuhzoknbv) = edojxsbrfu ypyhrzqgay (zudvnabluo ) View more	-	11 May 2020
				anti-CD20 monoclonal antibody (Flow Cytometry)	thtuawibpn(ubuhzoknbv) = chpbrkaxen ypyhrzqgay (zudvnabluo ) View more
FP208 (ERA2019)	Not Applicable	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis	242	Mabthera	gwtvbdnhly(hgcaokzyfg) = One episode of anaphylaxis was reported with Mabthera mdufedjavz (kojhjxkign ) View more	Positive	13 Jun 2019
				Truxima
NCT00547066 (Pubmed \| Haematologica) Manual	Phase 1/2	Purpura, Thrombocytopenic, Idiopathic CD20 Positive	50	Veltuzumab	yasfdvrlfn(dpavgzbyxh) = transient，mild to moderate hlhmcoliyd (xngxqmaomf )	Positive	01 Nov 2016
NCT00546793 (Pubmed \| Leukemia \| Leuk Lymphoma) Manual	Phase 1	Chronic Lymphocytic Leukemia	21	veltuzumab	bgwzdqjdhu(irmabivrrd) = iiyiddjwsz jvjrsietof (nutciylcjw ) View more	Positive	01 Jan 2016
NCT00989586 (Pubmed \| Int J Radiat Oncol Biol Phys \| Br J Haematol) Manual	Phase 1/2	B-Cell Lymphoma	35	milatuzumab+veltuzumab	eablgfojpe(vuipbrtxte) = tghmquasyc sgnuignyrd (dvdvytbsxg ) View more	Positive	01 Jun 2015
				Veltuzumab 200 mg/m(2) weekly + Milatuzumab 16 mg/kg weekly	-
ASCO2008	Phase 1/2	Lymphoma	-	Veltuzumab	vqiiinhknp(pesalotzko) = tbnvhnvxrz nyrpynzdup (oflbbzttsn ) View more	-	20 May 2008
ASCO2006	Phase 1/2	Non-Hodgkin Lymphoma	-	IMMU-106 (hA20) 120 mg/m^2	keanslnphr(zptfmzckmg) = wpphildhju wruxreqyud (nlvotebjze ) View more	-	20 Jun 2006

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