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Today (March 10），Good news in the treatment of multiple myeloma.Pfizer announced that the bispecific antibody new drug elranatamab (Elranatamab) has been officially approved for marketing in China.Indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.EnatuzumabIs aSimultaneous TargetingBispecific Antibody Targeting BCMA and CD3, which received FDA accelerated approval in August 2023 forRecurrent/RefractoryTreatment of MM patients.According to the introduction in Pfizer's press release,EnatuzumabAnti-Approval was granted based on the clinically meaningful overall response rate and duration of response from the global pivotal Phase 2 single-arm study MagnetisMM-3 and the separate Phase 1b/2 single-arm study MagnetisMM-8 conducted in China.MagnetisMM-3 clinical study data shows,With a median follow-up of 33.9 months, elotuzumab monotherapy continued to demonstrate deep and durable efficacy in triple-class refractory RRMM patients. The median duration of response (mDOR) has not yet been reached, with a 30-month DOR rate of 61.0%. The median progression-free survival (PFS) was 17.2 months, and the median overall survival (OS) was 24.6 months.And no new safety issues were observed.Full-property signal.
Multiple Myeloma (MM) is an incurable blood cancer.Most patients with MM will experience disease recurrence or develop resistance to treatment, necessitating subsequent therapy. Moreover, as the disease progresses, each recurrence becomes more aggressive, and the periods of remission achieved with new therapies gradually shorten.BCMA is considered to beIdeal Target for MM Treatment, it isA member of the TNF receptor superfamily, primarily expressed in MM cell lines and cells of MM patients, with expression increasing as the disease progresses.Elranatamab, as a bispecific antibody targeting BCMA, binds to BCMA on one end and to the CD3 receptor on the surface of T cells on the other end, thereby activating T cells to kill cancer cells expressing BCMA. In terms of administration,Subcutaneous injection of elranatamab is more convenient compared to intravenous injection and may reduce the occurrence of potential side effects such as cytokine release syndrome (CRS).In November 2022, it received theBreakthrough Therapy Designation。In August 2023, the Phase 2 study MagnetisMM-3 of this bispecific antibody for the treatment of multiple myeloma was published in a Nature sub-journal.Nature MedicineUp.The research paper noted in the abstract that elranatamabInduced deep and durable responses with manageable safety.In August of the same year, Pfizer announced that elranatamab received FDAAccelerated Approval, used to treat patients with relapsed/refractory multiple myeloma. At that time, Pfizer, in its official ChinesePress ReleaseIt was pointed out that,elranatamabDiscovered by Pfizer and achieved a leapfrog development from the first patient enrollment to approval in less than five years.This product is expected to become the new standard for multiple myeloma treatment.A few months later, in early 2024, Pfizer also submitted an application for the market approval of elranatamab injection to the NMPA in China and received acceptance from the Center for Drug Evaluation (CDE). Subsequently, the application was included.Priority Review, Publicized Indication: For use inAdult patients with relapsed or refractory multiple myeloma who have previously received at least three prior lines of therapy, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 monoclonal antibodies.This is also the approved indication.As of today, this bispecific antibody has officially received approval in China, which means that this new bispecific drug is expected to bring a new treatment option for patients with MM in China.[1] Pfizer’s Targeted Immunotherapy Eirio® (Epratuzumab) Approved in China for the Treatment of Relapsed or Refractory Multiple Myeloma. Retrieved Mar 10, 2025, from https://mp.weixin.qq.com/s/JYkzFxpmyBh9JlkYBlOWDg
[2] Pfizer’s ELREXFIO™ Receives U.S. FDA Accelerated Approval for Relapsed or Refractory Multiple Myeloma. Retrieved August 14, 2023, from https://www.businesswire.com/news/home/20230809028227/en
[3] China Drug Clinical Trial Registration and Information Disclosure Platform.From https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
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