RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (United States)

Structure/Sequence

Sequence Code 9075908L

Source: *****

Sequence Code 9075927H

Source: *****

Clinical Trials associated with Isatuximab-IRFC

NCT07600151

/ Not yet recruitingPhase 1/2IIT

A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

Start Date01 Dec 2026

Sponsor / Collaborator

Universitätsklinikum Hamburg-Eppendorf

[+2]

NCT07585760

/ RecruitingPhase 2IIT

A Prospective, Single-arm, Single-center, Phase II Study of BCMA/CD3 Bispecific Antibody Combined With CD38 Monoclonal Antibody in Newly Diagnosed Multiple Myeloma Patients With Renal Impairment

This study is a single-center, single-arm, open-label, Phase II interventional clinical trial designed to evaluate the efficacy and safety of a CM336 and isatuximab regimen in patients with newly diagnosed multiple myeloma (NDMM) accompanied by renal impairment ([eGFR] < 40 mL/min). Enrolled subjects will receive three consecutive cycles of induction therapy with CM336 in combination with isatuximab.

Start Date25 Jul 2026

Sponsor / Collaborator-

NCT07479979

/ RecruitingPhase 1/2IIT

Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.

Start Date01 Jul 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

100 Clinical Results associated with Isatuximab-IRFC

100 Translational Medicine associated with Isatuximab-IRFC

100 Patents (Medical) associated with Isatuximab-IRFC

508

Literatures (Medical) associated with Isatuximab-IRFC

01 Jul 2026·AMERICAN JOURNAL OF HEMATOLOGY

Navigating the Post‐ BCMA / GPRC5D Landscape: Efficacy of Selinexor, Bortezomib, and Dexamethasone After Sequential Immunotherapy Failure in Penta‐Refractory Multiple Myeloma—A Multicenter Analysis

Article

Author: Bartke, Leandra ; Harzer, Marie ; Brioli, Annamaria ; Khandanpour, Cyrus ; Cords, Leon ; Hillmann, Stefan M. ; Al‐Bazaz, Maximilian ; Weisel, Katja ; Bokemeyer, Carsten ; Holtick, Udo ; Artzenroth, Jule ; Kamili, Abdulaziz ; Leypoldt, Lisa ; Schaefers, Christoph ; Leitner, Theo ; Vorwerk, Jan ; Salwender, Hans ; Sonnemann, Piet ; Maulhardt, Markus ; Brinkert, Kerstin ; Kosch, Ricardo ; Richardson, Tim ; Alsdorf, Winfried

ABSTRACT:

Patients with relapsed/refractory multiple myeloma (RRMM) who are penta‐drug refractory, defined as resistant to two proteasome inhibitors, two immunomodulatory agents, and an anti‐CD38 monoclonal antibody, face a dismal prognosis, particularly after exposure to T‐cell–redirecting therapies. Selinexor, an oral exportin‐1 inhibitor, offers a distinct mechanism of action and may retain efficacy in this difficult setting. We conducted a retrospective analysis at six German tertiary centers (2023–2025) to evaluate the efficacy and safety of selinexor plus bortezomib and dexamethasone (SVd) in penta‐refractory MM after both BCMA‐ and GPRC5D‐targeted therapies. Eighteen patients were identified, with a median of seven prior lines of therapy. High‐risk cytogenetic abnormalities were present in seven cases, including del17p in six. The overall response rate (ORR) was 61%, including one complete, five very good partial, and five partial responses, and median progression‐free survival (PFS) was 4.3 months. Among nine patients (50%) with extramedullary disease (EMD), three achieved complete and one near‐complete EMD resolution. Two patients who had relapsed after CAR T‐cell treatment with idecabtagene vicleucel achieved partial and very good partial responses and were successfully transitioned to a second CAR T‐cell therapy with ciltacabtagene autoleucel. Hematologic toxicities under SVd were manageable, and no treatment‐related deaths occurred. SVd demonstrates meaningful activity in patients with penta‐refractory MM and prior failure of BCMA/GPRC5D‐targeted immunotherapies. The ORR of 61%, disease control in 78% of patients, and median PFS of 4.3 months support further evaluation of SVd in this highly refractory setting after failure of BCMA‐ and GPRC5D‐directed approaches.

01 Jun 2026·LEUKEMIA

Isatuximab induces antitumor activity in blastic plasmacytoid dendritic cell neoplasm through cellular cytotoxicity

Letter

Author: Miyake, Misayo ; Tsuyama, Naoko ; Momoki, Mamiko ; Koba, Yusuke ; Maruyama, Dai ; Inoue, Norihito ; Morita, Yuka ; Teramoto, Yukako ; Mima, Fuka ; Ishihara, Yuko ; Yamauchi, Nobuhiko ; Minowa, Sayuri ; Mishima, Yuko ; Takayama, Tomoko ; Takeuchi, Kengo ; Shirouchi, Yuko

04 May 2026·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Isatuximab: an anti-CD38 therapy that addresses unmet needs and mechanisms of resistance in multiple myeloma

Review

Author: Merz, Lauren E. ; Franz, Joseph ; Fortune, Anne ; O’Gorman, Peter ; Lee, Hans C. ; Salman, Taya Jamal ; Berdeja, Jesus ; Midha, Shonali ; Hartley-Brown, Monique ; Rifkin, Robert ; Mo, Clifton ; Liu, Yuxin ; Richardson, Paul G. ; Laubach, Jacob ; Nicholson, Taylor ; Nadeem, Omar

INTRODUCTION:

In recent years, anti-CD38 antibodies have become integral to the multiple myeloma (MM) treatment armamentarium and greatly improved depth of response and patient outcomes. Isatuximab, an anti-CD38 antibody, is approved for both newly diagnosed MM and relapsed/refractory MM. Understanding the distinct mechanistic features of isatuximab within the anti-CD38 drug class provides further insight into treatment selection.

AREAS COVERED:

This review discusses the unique mechanism of action of isatuximab, supporting preclinical data, and differentiation from other anti-CD38 antibodies. It will delve into evidence demonstrating the favorable benefit-risk profile of isatuximab in broad patient populations across the MM treatment continuum.

EXPERT OPINION:

Isatuximab elicits antitumor activity via multiple tumor-targeting pathways. The direct cytotoxic mechanism of isatuximab is a key differentiator from other anti-CD38 antibodies and translates into clinical benefits in patients with MM. Isatuximab only relies partly on complement-dependent cytotoxicity activity for its antitumor activity, which may have beneficial prognostic implications for patients with 1q21 chromosomal abnormalities and extramedullary disease. This is supported by clinical data, which demonstrate a favorable benefit/risk profile in MM patients including difficult-to-treat patients with poor prognostic outcomes. Further, addition of the novel on-body injector to isatuximab administration modalities may provide advantages over current administration methods.

277

News (Medical) associated with Isatuximab-IRFC

14 Jul 2026

·www.globenewswire.com

Press Release: Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector

Sanofi’s subcutaneous Sarclisa Escena approved in the US as first anticancer treatment administered via on-body injector Sarclisa Escena administered via the CirCLIQ® on-body injector (OBI) offers a treatment experience designed with patients and HCPs in mindThe first anticancer treatment to be administered through an OBI, and the first MM treatment available by both SC OBI and manual SC administration in the USEfficacy of Sarclisa now available in SC formulation with innovative OBI across approved combinations and lines of therapy Paris, July 10, 2026. The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. With the approval, Sarclisa Escena is the first anticancer treatment to be administered through both an on-body injector (OBI) and manual SC administration. The FDA approval was supported by multiple studies, including the pivotal IRAKLIA phase 3 non-inferiority study, which demonstrated Sarclisa Escena administered subcutaneously via an OBI provided similar efficacy, pharmacokinetics and safety compared to IV infusion, along with a significantly shorter treatment time and fewer infusion-related reactions. “Multiple myeloma is a malignancy that often requires frequent IV infusions or manual subcutaneous injections. Treatment administration can be a cumbersome experience for patients, while also placing a strain on providers by requiring physical effort to push high-resistance syringes for several minutes,” said Sikander Ailawadhi, MD, Professor of Medicine, Division of Hematology/Oncology at Mayo Clinic Florida, US, and the principal investigator of the IRAKLIA study. “The comparable efficacy observed across multiple studies and the patient-centric design of the OBI offers an opportunity to impact the patient experience while upholding Sarclisa’s consistent efficacy.” The studies were conducted using Enable Injections’ hands-free OBI, an automated injector designed to deliver subcutaneously high-volume medicines with the push of a button, to administer Sarclisa Escena. The OBI uses a retractable 30g needle that is shorter and thinner compared to the needles commonly used for large-volume injections. The approval of Sarclisa Escena with Enable Injections’ CirCLIQ OBI – developed using the enFuse® platform – offers the potential to change the overall patient experience in MM treatment. “Sarclisa is the cornerstone of our oncology franchise, and we have always been confident in it being widely adopted as a potential best-in-class therapy,” said Manuela Buxo, Executive Vice President, Head of Specialty Care at Sanofi. “The approval of Sarclisa Escena subcutaneous formulation administered with the CirCLIQ is a definitive step in this direction. More than 70,000 patients worldwide have benefitted from Sarclisa, delivering predictable and important efficacy and safety across multiple combinations and lines of therapy. Today, we are proud to bring innovation that will empower physicians to enhance the treatment experience for patients, offering greater simplicity, flexibility and convenience.” In addition, the CirCLIQ may streamline the administration process for providers, offering the potential to reduce the physical burden on nurses with a hands-free device and providing more freedom for patient monitoring and interaction. “The introduction of Sarclisa Escena with the innovative CirCLIQ on-body injector represents a significant advancement in multiple myeloma care,” said Donna D. Catamero, ANP-BC, OCN, CCRC, Associate Director, Myeloma Research; Adjunct Faculty, Mount Sinai Phillips School of Nursing and International Myeloma Foundation Nurse Leadership Board member. “For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients.” In the IRAKLIA phase 3 study, the first to incorporate the use of an OBI in the treatment of MM, Sarclisa SC administered via an OBI in combination with pomalidomide and dexamethasone (Pd) resulted in a 71.1% (187/263) objective response rate (ORR), compared to 70.5% (189/268) with Sarclisa IV-Pd, establishing non-inferiority (relative risk 1.008; 95% confidence interval: 0.903-1.126), in adult patients with relapsed or refractory MM (R/R MM) who have received at least one prior line of treatment. The overall safety profile of Sarclisa SC-Pd observed in this study was consistent with the established safety profile of Sarclisa IV-Pd. While 25% of patients treated with Sarclisa IV-Pd experienced systemic administration reactions, 1.5% of patients treated with Sarclisa SC-Pd experienced those reactions. No new safety concerns were observed, except for injection site reactions (ISRs) that occurred in 0.4% of OBI injections (n=19/5,145 injections). Nearly all ISRs were grade 1, except for one episode of grade 2. The most common adverse reactions (≥20%) were upper respiratory tract infection, fatigue,pneumonia, musculoskeletal pain, and diarrhea. The most common hematology laboratoryabnormalities (≥40%) were decreased leukocytes, decreased neutrophils, decreased lymphocytes, decreased platelets, and decreased hemoglobin. Sarclisa is currently approved across three indications in the US, including in combination with bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma (NDMM) patients not eligible for autologous stem cell transplant. In R/R MM, Sarclisa is approved in combination with Pd in patients who have received ≥two prior therapies, including lenalidomide and a proteasome inhibitor and have relapsed on the last therapy, as well as in combination with carfilzomib and dexamethasone in patients who have received one to three prior lines of therapy. About the IRAKLIA studyIRAKLIA (clinical study identifier: NCT05405166) was a randomized, open-label, pivotal phase 3 study evaluating the non-inferiority of Sarclisa Escena administered at a fixed dose of 1,400 mg SC in combination with Pd via OBI versus weight-based dosed Sarclisa IV in combination with Pd in adult patients with R/R MM who have received at least one prior line of therapy. The major efficacy measures were ORR, defined as the proportion of patients with stringent complete response (CR), CR, very good partial response, and partial response according to the 2016 International Myeloma Working Group criteria assessed by Independent Review Committee, and observed Sarclisa Escena mean concentration before dosing (Ctrough) at steady state (pre-dose at cycle 6, dose 1 [C6D1]), defined as observed Sarclisa Escena plasma concentrations.About Enable InjectionsCincinnati-based Enable Injections is a global healthcare innovation company committed to improving the patient treatment experience through the development and manufacturing of the enFuse® On-Body Delivery System. An innovative wearable technology, the enFuse system is designed to deliver large volumes of pharmaceutical and biologic therapeutics via subcutaneous administration, with the aim of improving convenience, supporting superior outcomes, and advancing healthcare system economics. For more information, visit www.enableinjections.com. About SarclisaSarclisa (isatuximab-irfc) has been approved in almost 60 countries across four indications for certain patients with NDMM and R/R MM.Sarclisa-based regimens have been prescribed to treat more than 70,000 patients worldwide.Sarclisa SC (Sarclisa Escena in the US), the subcutaneous formulation of Sarclisa, is approved in the US, in the EU, and in the UK, in combination with approved standard-of-care regimens for the treatment of patients with MM across all currently approved indications for Sarclisa IV in these countries. It is the first anticancer treatment to be administered through an OBI, and the only anti-CD38 monoclonal antibody available in MM to offer the flexibility of both SC OBI and manual injection administration. Sarclisa SC is approved in Japan for manual injection and a regulatory submission for the CirCLIQ on-body injector (OBI), based on the enFuse platform and submitted by Enable Injections, is under review. At Sanofi, we are building on a long-standing commitment to oncology as we continue to chase the miracles of science to improve the lives of those living with cancer. We are committed to transforming cancer care by developing innovative, first and best-in-class immunological and targeted therapies for rare and difficult-to-treat cancers with high unmet need.For more information on Sarclisa clinical studies, please visit www.clinicaltrials.gov. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY Media RelationsSandrine Guendoul | + 33 6 25 09 14 25 | sandrine.guendoul@sanofi.com Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com Léo Le Bourhis | + 33 6 75 06 43 81 | leo.lebourhis@sanofi.com Victor Rouault | +1 617 356 4751 | victor.rouault@sanofi.com Timothy Gilbert | + 1 516 521 2929 | timothy.gilbert@sanofi.com Léa Ubaldi | +33 6 30 19 66 46 | lea.ubaldi@sanofi.comEkaterina Pesheva | +1 410 926 6780 | ekaterina.pesheva@sanofi.comLaura Romby | +33 6 74 16 74 29 | laura.romby@sanofi.com Investor RelationsThomas Kudsk Larsen | + 44 7545 513 693 | thomas.larsen@sanofi.com Alizé Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com Keita Browne | + 1 781 249 1766 | keita.browne@sanofi.com Nathalie Pham | + 33 7 85 93 30 17 | nathalie.pham@sanofi.com Nina Goworek | +1 908 569 7086 | nina.goworek@sanofi.com Thibaud Châtelet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com Yun Li | +33 6 84 00 90 72 | yun.li3@sanofi.com Sanofi forward-looking statementsThis press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions regarding the marketing and other potential of the product; regarding potential future events and revenues from the product. Words such as “expect,” “anticipate,” “believe,” “intend,” “estimate,” “plan,” “can,” “contemplate,” “could,” “is designed to,” “may,” “might,” “potential,” “objective,” "attempt," “target,” “project,” "strategy," "strive," "desire," “predict,” “forecast,” “ambition,” “guideline,” "seek," “should,” “will,” "goal," or the negative of these and similar expressions are intended to identify forward-looking statements. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks, uncertainties and assumptions include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful; authorities’ decisions regarding whether and when to approve a product candidate; political pressure in the United States to mandate lower drug prices including “most favored nation” pricing for State Medicaid programs; the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues; competition in general; risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the French Markets Authority (AMF) made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2025 or contained in our periodic reports on Form 6-K. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. In light of these risks, uncertainties and assumptions, you should not place undue reliance on any forward-looking statements contained herein. All trademarks mentioned in this press release are the property of the Sanofi group with the exception of enFuse and CirCLIQ. Attachment Press_Release

Phase 3Clinical ResultDrug Approval

13 Jul 2026

·www.biospace.com

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

Application based on results from SUCCESSOR-2 trial showing oral CELMoD mezigdomide in combination with carfilzomib and dexamethasone significantly improved progression-free survival vs. standard of care in this patient population The U.S. FDA has assigned a target action date of May 13, 2027 PRINCETON, N.J.--(BUSINESS WIRE)-- $BMY #BMS -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM). Mezigdomide is an oral cereblon E3 ligase modulator, or CELMoD, for the treatment of multiple myeloma. The FDA has granted a Prescription Drug User Fee Act (PDUFA) date of May 13, 2027 for this indication. “The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programs, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “We’re rapidly progressing the development of our CELMoD pipeline and are committed to leveraging this platform to bring the next wave of advances for patients in both hematologic malignancies and solid tumors.” The filing was based on positive results from the Phase 3 SUCCESSOR-2 trial (NCT05552976) showing MeziKd demonstrated a clinically meaningful and statistically significant improvement in progression-free survival (PFS) (95% CI: 18.0 months vs. 8.3 months [HR:0.48; p<0.0001]), representing a 52% reduction in the risk of disease progression or death compared with Kd in patients with relapsed or refractory multiple myeloma, including those at first relapse after prior treatment with an anti-CD38 monoclonal antibody and lenalidomide. The safety pro MeziKd was consistent with that observed in prior studies of mezigdomide, as well as with the known safety profiles of the individual agents in the regimen. Results were recently presented at the 2026 American Society of Clinical Oncology (ASCO ® ) Annual Meeting as a late-breaking oral presentation and published in The Lancet . Bristol Myers Squibb thanks the patients and investigators involved with the Phase 3 SUCCESSOR-2 study. About mezigdomide Mezigdomide is an oral CELMoD specifically optimized to modulate cereblon for maximal and rapid degradation of Ikaros and Aiolos target proteins, leading to higher multiple myeloma cell killing and immune stimulation than traditional immunomodulatory agents. Pre-clinical data suggest mezigdomide enhances T cell function and prevents and reinvigorates an exhausted immune system. Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial vs. standard of care regimen in relapsed or refractory multiple myeloma. About SUCCESSOR-2 There is a growing number of patients exposed and/or refractory to lenalidomide and anti-CD38 antibodies from first relapse. The SUCCESSOR-2 trial addressed this growing need. SUCCESSOR-2 (NCT05552976) is an inferential, seamless Phase 3, multicenter, randomized, open-label study evaluating the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). The primary endpoint of the Phase 3 study is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, time to progression, time to next treatment, minimal residual disease negativity, and health-related quality of life. Dose optimization for mezigdomide occurred in stage 1. The mezigdomide dose selected for stage 2 of the study was 1.0 mg. In total, 479 patients (288 MeziKd at 1.0 mg of mezigdomide; 191 Kd) were included in the analysis. Across both arms, median age was 68 with 25.1% of patients ≥75 years old; median number of prior therapies was 2; 92.1% of patients were triple-class-exposed, with 85.8% refractory to an anti-CD38 monoclonal antibody and 75.8% to lenalidomide; 37.2% were exposed to pomalidomide and 7.3% to anti-BCMA treatment. At data cutoff, median follow-up was 10.6 months with 52.4% (MeziKd) and 31.4% (Kd) of patients still on treatment. About Targeted Protein Degradation and CELMoD Targeted protein degradation (TPD) is a differentiated research platform at Bristol Myers Squibb built on more than two decades of scientific expertise, providing new avenues to degrade therapeutically relevant proteins that were previously considered difficult to address. BMS is the only company that has successfully developed and commercialized protein degrader agents for the treatment of multiple myeloma. These agents, known as immunomodulatory drugs (IMiDs), helped establish the current standard of care in the treatment of this disease, which remains without a cure. BMS is building on this foundation with several investigational protein degraders in clinical trials, leveraging three different modalities including CELMoD, ligand-directed degraders (LDDs), and degrader antibody conjugates (DACs). This three-pronged approach enables matching the right therapeutic modality to a molecular mechanism of action to modulate targets most effectively and ultimately provides more opportunities for potential breakthroughs that may offer meaningful new options for patients across a broad range of diseases, in and beyond hematology and oncology. Learn more about the science behind TPD at Bristol Myers Squibb here . About Bristol Myers Squibb: Transforming Patients’ Lives Through Science At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn , X , YouTube , Facebook and Instagram . Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such combination treatment for such indication will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that acceptance of the New Drug Application does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news Contacts Bristol Myers Squibb Media Inquiries: media@bms.com Investors: investor.relations@bms.com

Clinical ResultPhase 3ASCONDA

10 Jul 2026

·www.fiercepharma.com

Sanofi snags FDA thumbs up for Sarclisa as 1st cancer drug delivered by on-body injector

Sanofi has scored FDA approval for its subcutaneous version of Sarclisa, giving the multiple myeloma treatment a potential boost in its competition with Johnson & Johnson’s powerhouse Darzalex. Sanofi’s new formulation, which is dubbed Sarclisa Escena, now becomes the first subcutaneous anticancer drug that can be administered manually or by an on-body injector (OBI). The endorsement for Sarclisa Escena applies to each of the indications for which its intravenous (IV) formulation is approved. The endorsement was backed by multiple trials, including the phase 3 Iraklia study, which was the first to use an OBI in dosing multiple myeloma patients and showed that Sarclisa Escena reduced treatment time and produced similar efficacy and safety compared to the drug's IV formulation. Sarclisa Escena administered via an OBI in combination with Bristol Myers Squibb’s Pomalyst and the corticosteroid dexamethasone (Pd) yielded a 71.1% objective response rate (ORR), compared to 70.5% with Sarclisa IV-Pd, establishing non-inferiority in adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of treatment. Sarclisa Escena is delivered by Enable Injections’ CirCLIQ hands-free automated device. The Cincinnati-based company gained its first FDA approval three years ago for its enFuse OBI to administer Apellis Pharmaceuticals’ paroxysmal nocturnal hemoglobinuria drug Empaveli. The device employs a retractable 30g needle that is shorter and thinner compared to the needles commonly used for large-volume injections, Sanofi said. Introduction of the OBI option “represents a significant advancement in multiple myeloma care,” Donna Catamero, the Associate Director, Myeloma Research at Mount Sinai Phillips School of Nursing, said in a release. “For nurses and physicians treating patients with multiple myeloma, this automated system has the potential to meaningfully reduce administrative burden, simplifying how therapy is delivered and giving healthcare teams more capacity to focus on their patients,” Catamero added. The innovation also gives Sanofi a better chance to vie with J&J. While Sarclisa and Darzalex are from the same CD38 drug class, Darzalex reached the market five years earlier (2015), and gained a nod for its subcutaneous version, Darzalex Faspro, in 2020. Darzalex rang up sales of $14.4 billion in 2025, which were up 23%, while Sanofi reported sales of Sarclisa at 588 euros ($700 million), good for an increase of 28%. “Sarclisa is the cornerstone of our oncology franchise and we have always been confident in it being widely adopted as a potential best-in-class therapy,” Manuela Buxo, EVP and Sanofi’s Head of Specialty Care, said in a statement. In a statement from J&J, Imran Khan, M.D., VP, U.S. Medical Affairs, hematology, stressed that Darzalex is approved in more indications than any anti-CD38 monoclonal antibody. "Darzalex Faspro offers convenient once-monthly subcutaneous delivery, taking 3-5 minutes per injection and enabling patients to receive monthly dosing starting at 6 months," Khan added. "Our focus remains on deepening that impact as we continue to change standards of care." Sarclisa is approved for three indications, including first-line use in patients ineligible for stem cell transplant. In this indication, Sarclisa is added to J&J and Takeda’s Velcade, plus Bristol Myers Squibb’s Revlimid and the corticosteroid dexamethasone. Sarclisa was originally approved in combination with Pd for patients who had received at least two prior therapies, including Revlimid and a protease inhibitor such as Velcade. It was also endorsed for second-line use with Amgen’s Kyprolis and dexamethasone. The FDA was originally scheduled to decide on the new version of Sarclisa by April 22 before pushing back the date by three months. In June, Europe signed off on subcutaneous Sarclisa, making it the first anticancer therapy that could be delivered by an OBI in the bloc.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Isatuximab-IRFC

External Link

KEGG	Wiki	ATC	Drug Bank
-	Isatuximab-IRFC	L01	DB14811

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Relapse multiple myeloma	Japan	Sanofi KK	29 Jun 2020
Multiple Myeloma	United States	Sanofi-Aventis U.S. LLC	02 Mar 2020

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent Multiple Myeloma	Phase 3	United States	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	China	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Japan	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Argentina	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Australia	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Brazil	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Canada	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Chile	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	Czechia	Sanofi	23 Jun 2022
Recurrent Multiple Myeloma	Phase 3	France	Sanofi	23 Jun 2022

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04045795 (IRAKLIA, ASCO2026 \| EHA2026)	-	Multiple Myeloma	349	Isatuximab SC OBI + pomalidomide + dexamethasone	hnsdhtznkw(pjayjfwkev) = vjamwyctqr fljzqvyccn (uksorlbepw ) View more	Positive	29 May 2026
				Isatuximab SC OBI + carfilzomib + dexamethasone	ygoqcoimvz(dbmqtcmetn) = fsadtxlhnr ojbsgpjlbe (mdbzhyoyxw )
NCT05922501 (ISABELA, ASCO2026)	Phase 2	Relapse multiple myeloma	17	IsatuximabDexamethasonePomalidomideBelantamab mafodotin + IsatuximabDexamethasonePomalidomideBelantamab mafodotin + IsatuximabDexamethasonePomalidomideBelantamab mafodotin + IsatuximabDexamethasonePomalidomideBelantamab mafodotin	azgqyoinut(cohmbqaqjp) = Grade 3-4 hematologic adverse events (AEs) included neutropenia (53%), thrombocytopenia (29%), and anemia (12%). Common non-hematologic AEs (all; grade 3-4) included blurred vision (65%; 6%); fatigue (65%; 0%); hypertension (59%; 6%); diarrhea (53%; 0%); and AST/ALT increase (47%; 6%). Infections occurred in 35% with no grade ≥3 events. apojnyifcm (sowbxnsyuw ) View more	Positive	29 May 2026
				Dexamethasone (CD38-antibody-naïve patients)
NCT05704049 (IZALCO, EHA2026)	Phase 2	Relapse multiple myeloma	74	Isa SC Manual + Kd (Non-randomized Cohort (Part 1))	hlkrdxkiga(pwoshlmdmc) = rgsgxygeil tvxcabjwgc (rjomtkvfff ) View more	Positive	21 May 2026
EHA2026	Not Applicable	Multiple Myeloma	20	Isatuximab Combination (Daratumumab-Refractory Multiple Myeloma)	hydhegyktj(kgijkuobbz) = lzlihbbzuj ihpuffjutd (decwpkkczb ) View more	Positive	12 May 2026
EHA2026	Not Applicable	Multiple Myeloma	21	Isa-VRd	nyoruivcea(cqzjgtwios) = Under Isa-VRd, the main adverse events observed were grade 2 anemia, grade 1 thrombocytopenia, grade 2 hypertension, and one case of esophageal abscess. Under Dara-VRd, grade 3 hematologic toxicity was reported in one patient, as well as one episode of arrhythmia. tusremucpj (vihpvwosbi )	Positive	12 May 2026
				Dara-VRd
EHA2026	Not Applicable	Smoldering Multiple Myeloma	12	Isatuximab+Lenalidomide+Oral Cyclophosphamide+Dexamethasone	ihgpavkerx(etkqrawvap) = hdqpfltpjr yqyjwsxswb (udbkdkjszf ) View more	Positive	12 May 2026
NCT04891809 (AGMT MM04, EHA2026)	Phase 3	Multiple Myeloma	137	Isatuximab-Lenalidomide-Dexamethasone (Isa-Rd)	uwxxrsuzax(xjenmjdmui) = There was no significant difference in AEs between both groups with the exception of procedural complications (15.7% vs.1.5%, p=0.005), and weight loss (8.6% vs. 0%, p=0.028) which were more frequent in the Isa-Rd group. oqodspsmix (szinhofkqt ) View more	Positive	12 May 2026
				RD induction followed by R maintenance
EHA-6434 (EHA2026)	Not Applicable	Multiple Myeloma cytogenetic risk	1,576	D-VRd (daratumumab, bortezomib, lenalidomide, dexamethasone)	nunwpzknpq(efgksngarn): HR = 0.61 (95.0% CI, 0.39 - 0.93)	Positive	12 May 2026
				Isa-RVd (isatuximab, bortezomib, lenalidomide, dexamethasone)
NCT03617731 (GMMG-HD7, EHA2026)	Phase 3	Multiple Myeloma First line	662	Isatuximab + Lenalidomide (Len) + Bortezomib + Dexamethasone (Isa-RVd)	agyttzvmlj(qtwphgbzwm): Difference = 2.26 (95.0% CI, -4.88 to 9.39) View more	Positive	12 May 2026
				Lenalidomide (Len) + Bortezomib + Dexamethasone (RVd)
NCT05147493 (ASH2025)	Phase 2	anti-CD38 monoclonal antibody	51	Isatuximab + Lenalidomide (maintenance)bortezomib + cyclophosphamide + dexamethasone (induction) + Isatuximab + Lenalidomide (maintenance)bortezomibde cyclophosphamide	lcfydnshdo(wchvjzqbcl) = qhatvjuapa lehbtspido (utbmkywqod ) View more	Positive	06 Dec 2025

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