The number of BCMA-directed therapies for treating multiple myeloma grew as the US Food and Drug Administration gave accelerated approval to Elrexfio (elranatamab-bcmm), Pfizer Inc.’s anti-BCMAxCD3 bispecific antibody. Given its flat dosing, dosing schedule and adverse event profile, the company sees the potential for the drug to gain traction in the community oncology setting rather than staying relegated to academic cancer centers, as BCMA-directed therapies have generally been to date.
The FDA gave the green light to Elrexfio on 14 August for patients who have received at least four prior lines of therapy that include a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, based on results from the Phase II MagnetisMM-3 clinical trial. Elrexfio is one of the key pipeline drugs Pfizer expects will help drive company growth in the second half of the decade despite the upcoming loss of exclusivities of several top-selling drugs
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