FDA Approves Pfizer’s Blood Cancer Therapy
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Pfizer Inc’s blood cancer therapy, Elrexfio (elranatamab-bcmm). This treatment has been approved for adult patients with relapsed or refractory multiple myeloma (RRMM) who have undergone at least four prior lines of therapy.
The approval of Elrexfio was based on the results from the single-arm Phase 2 MagnetisMM-3 study. However, continued approval for this indication is dependent on the verification of clinical benefit in one or more confirmatory studies.
Elrexfio is an immunotherapy that utilizes subcutaneously administered bispecific antibodies (BsAb) to bind to B-cell maturation antigen (BCMA)-CD3. By joining BCMA on myeloma cells and CD3 on T cells, Elrexfio activates T cells to effectively eliminate myeloma cells.
Reuters reported that Elrexfio will be sold in the United States at list prices of $7,556 and $13,051 for the 44 mg and 76 mg vial, respectively. The therapy’s list price is expected to be $41,500 per month, although Pfizer anticipates a lower monthly price of approximately $26,000 when patients transition to biweekly dosing.
Pfizer estimates that Elrexfio could generate potential peak revenues of over $4 billion.
The labeling for Elrexfio includes a boxed warning for cytokine release syndrome and neurological toxicity, including immune effector cell-associated neurotoxicity syndrome. The therapy also carries warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo-fetal toxicity.
In trading news, shares of Pfizer fell 0.42% to $35.92 during Tuesday’s pre-market session.
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