Pfizer Inc. (NYSE:PFE) has received conditional marketing authorization from the European Commission (EC) for its BCMA-CD3-targeted bispecific antibody, Elrexfio (elranatamab), designed to treat relapsed/refractory multiple myeloma (RRMM). This approval applies to 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 seen 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 group. This approval follows the recommendation for conditional marketing authorization given 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, has shown deep and durable responses with manageable tolerability in a convenient dosing format. In August, the U.S. Food and Drug Administration (FDA) granted accelerated approval for Elrexfio to treat RRMM. However, the U.S. label carries a boxed warning for cytokine release syndrome and neurologic toxicity.

Despite this positive development, Pfizer’s shares have experienced a 43.8% decline this year, contrasting with a 4.3% increase in the industry.

Elrexfio’s journey continues through the MagnetisMM program, exploring its potential for expanded use in earlier lines of treatment, both as a standalone agent and in combination therapy across the spectrum of myeloma progression, from newly diagnosed cases to RRMM.

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