Pfizer Inc. (NYSE:PFE) has received conditional marketing authorization from the European Commission (EC) for its BCMA-CD3-targeted bispecific antibody, Elrexfio (elranatamab), to treat relapsed/refractory multiple myeloma (RRMM). The approval is specifically for heavily pre-treated patients who have undergone at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody and have experienced disease progression on the last therapy.
The EC’s decision was based on data from cohort A of the phase II MagnetisMM-3 study, demonstrating meaningful responses in the specified patient population. The approval aligns with the earlier recommendation for conditional marketing authorization provided by the European Medicines Agency’s Committee for Medicinal Products for Human Use in October.
Elrexfio, an off-the-shelf fixed-dose subcutaneous BCMA-CD3-targeted immunotherapy, offers deep and durable responses with a manageable tolerability profile and convenient dosing. The drug received accelerated approval from the U.S. Food and Drug Administration (FDA) for RRMM treatment in August. However, the FDA’s approval comes with a boxed warning for cytokine release syndrome and neurologic toxicity.
Pfizer’s Elrexfio continues to be studied for expanded use in earlier lines of treatment, both as a standalone therapy and in combination across the spectrum of myeloma progression, from newly diagnosed multiple myeloma to RRMM.
The approval of Elrexfio in the EU marks a significant milestone for Pfizer in providing a new treatment option for RRMM patients who have undergone extensive prior therapies. The company aims to further explore the drug’s potential in diverse treatment scenarios for multiple myeloma.
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