pharmaphorum February 22, 2024
Regeneron’s bid to join the market for BCMA-targeted bispecific antibodies for multiple myeloma is nearing a conclusion, with the FDA starting a priority review of its linvoseltamab drug candidate.
The US regulator is due to decide on the marketing application for BCMAxCD3-targeting linvoseltamab as a fourth-line therapy for relapsed or refractory multiple myeloma by 22nd August, and the drug is also under review by the EMA.
Regeneron is, however, playing catch-up in the category with Johnson & Johnson’s Tecvayli (teclistamab) and Pfizer’s Elrexfio (elranatamab), which are already FDA-approved in this indication, and the jury is out on whether linvoseltamab will be able to carve out a niche in the increasingly crowded multiple myeloma market.
Data from the phase 1/2 LINKER-M1...
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