FDA grants accelerated approval to Pfizer’s Elrexfio

Betsy Goodfellow | August 15, 2023 | News story | Medical Communications Elrexfio, FDA, Oncology, Pfizer, accelerated approval 

Pfizer has that the US Food and Drug Administration (FDA) has granted accelerated approval to Elrexfio (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have had at least four prior treatments.

This approval follows results from the single-arm phase 2 MagnetisMM-3 trial, however continued approval depends upon verification of the drug’s clinical benefit from confirmatory trials.

The drug is a subcutaneously delivered B-cell maturation antigen (BCMA)-CD3-directed bispecific antibody (BsAb) immunotherapy, which binds to BCMA on the myeloma cells and CD3 on T-cells to bring them together and activate the T-cells, killing the myeloma cells.

Angela Hwang, chief commercial officer and president of Global Biopharmaceuticals Business at Pfizer, commented: “Elrexfio 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. With significant responses in a patient population with highly refractory disease, we believe Elrexfio 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 expansive MagnetisMM programme.”

Ajay Nooka, MD MPH, MagnestisMM clinical trial investigator and director of the Multiple Myeloma Program at Winship Cancer Institute of Emory University, US, added: “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. By offering durable clinical response with an established safety profile and the convenience of subcutaneous administration, Elrexfio provides a much-needed new option for heavily pre-treated multiple myeloma patients who are struggling with relapsed myeloma.”

Betsy Goodfellow

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