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FDA granted accelerated approval to Elrexfio (elranatamab-bcmm) for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
Pfizer announced that FDA has granted accelerated approval to its multiple myeloma treatment, Elrexfio (elranatamab-bcmm), on Aug. 14, 2023. The treatment is approved 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-cluster of differentiation 38 monoclonal antibody. According to a company press release, approval was based on a Phase II trial (MagnetisMM-3), and continued approval is contingent upon verification of clinical benefit in a confirmatory trial.
Elranatamab-bcmm is a subcutaneously delivered B-cell maturation antigen (BCMA)-cluster of differentiation three (CD3)-directed bispecific antibody immunotherapy. The treatment is designed to bind to BCMA on myeloma cells and CD3 on T-cells, bringing them together and activating the T-cells to kill myeloma cells.
According to the press release, data from the Phase II study showed meaningful responses among heavily pretreated RRM patients who received elranatamab-bcmm as their first BCMA-directed therapy. Among patients who received four or more lines of therapy prior to elranatamab-bcmm, overall response rate was 58%, with 82% maintaining the response for at least nine months.
“[Elranatamab-bcmm] reflects our ongoing commitment to developing scientific breakthroughs that meaningfully improve outcomes for people with cancer. Discovered at Pfizer, we advanced this therapy from a first-in-patient trial to approval in less than five years, because we know that time is life for people living with multiple myeloma,” said Angela Hwang, chief commercial officer and president, Global Biopharmaceuticals Business, Pfizer, in the release. “With significant responses in a patient population with highly refractory disease, we believe [elranatamab-bcmm] is poised to potentially become the new standard of care for multiple myeloma, as we plan to build upon this indication with continued development across the … MagnetisMM program.”
“Most multiple myeloma patients will experience relapse or resistance of their disease to treatment, often facing increased symptom burden and lowering their chance of surviving longer with each attempted line of therapy,” said Ajay Nooka, director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University and MagnetisMM clinical trial investigator, in the release. “By offering durable clinical response with an established safety profile and the convenience of subcutaneous administration, [elranatamab-bcmm] provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma.”
Prior to this accelerated approval, elranatamab-bcmm received breakthrough therapy and orphan drug designations from FDA. The FDA review was conducted under Project Orbis, a framework for concurrent submission and review of oncology drugs among international partners to potentially expedite approvals; five countries (Switzerland, Brazil, Canada, Australia, and Singapore) are currently participating. The Japanese Ministry of Health, Labour and Welfare is currently evaluating a new drug application for elranatamab-bcmm, and the European Medicines Agency is evaluating a marketing authorization under the Priority Medicines scheme.