Regeneron Pharmaceuticals’ drug candidate for multiple myeloma, linvoseltamab, was rejected by the FDA due to issues with the treatment’s third-party manufacturer. The FDA cited unresolved findings with the contract manufacturer, requiring a reinspection before approval. Regeneron’s drug is a bispecific antibody designed to target cancer cells and activate T cells. Clinical studies showed promising results, with a significant percentage of patients achieving complete or partial responses after treatment. While other companies have already launched similar drugs for multiple myeloma, Regeneron’s therapy could have an advantage as an earlier line of treatment. An FDA reinspection of the manufacturing facility is expected in the coming months.
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FDA Rejection Delays Regeneron From Competing With J&J, Pfizer in Multiple Myeloma
