Elrexfio FDA Approval For Refractory Multiple Myeloma

Release Date: 17-Aug-2023

On August 14, 2023, Pfizer’s Elrexfio (elranatamab-bcmm) became the most recent antibody to receive from the US FDA, and the 11th overall to receive an FDA approval. Elranatamab is a bispecific antibody designed to target the BCMA, expressed by multiple myeloma cells, and CD3, expressed by T cells, thus bridging the gap between the two and expediting the cancer cell elimination process. Elrexfio has been developed as an off-the-shelf, fixed-dose BCMA-directed therapy with subcutaneous administration, which makes it convenient to use compared to other immunotherapies indicated for multiple myeloma treatment.


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Meaningful responses obtained in Pfizer’s phase II MagnetisMM-3 study served as the basis for elranatamab’s FDA accelerated approval. The overall response rate in patients who had not undergone BCMA-directed therapy prior was 58%, while in patients who had received a BCMA-directed therapy before, the overall response rate was 33%. Participants also experienced adverse effects varying in severity. Elranatamab is now being assessed in further late-phase clinical trials, and the results obtained from these are anticipated to help it gain a full FDA approval. Further, Elrexfio is also under regulatory review by the EMA, and an affirmative response is anticipated considering CHMP has recommended the drug for adoption in the EU.


A few days before the FDA approval of Elrexfio, the agency had approved Johnson and Johnson’s Talvey for the same indication. Therefore, competition between the two candidates is inevitable. However, Elrexfio comes as a fixed-dose therapeutic, which gives it an advantage over others. This patient-convenient factor is anticipated to translate into market sales for the drug, which will help increase the share of bispecific antibodies in the global market for cancer drugs. The global market for bispecific antibodies was valued at US$ 1.87 billion in the first quarter of 2023, which is expected to increase as more bispecific antibodies, like Elrexfio and Talvey, gain approval.


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