The FDA declined to approve the bispecific antibody linvoseltamab by Regeneron for the treatment of relapsed/refractory multiple myeloma due to issues at a third-party manufacturer. The manufacturer believes the issues have been resolved and a follow-up FDA inspection is expected in the coming months. This delay in approval was anticipated by Regeneron, as previously disclosed during an earnings call. The medication showed promising results in a phase 1/2 trial, with 71% of patients achieving an overall response and a 75.3% survival probability at 12 months. If approved, linvoseltamab would have been the first of its kind on the market, joining competitors with a reported cost of around $40,000 per month.
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FDA Issues Complete Response Letter for Myeloma Drug
