The U.S. Food and Drug Administration approved GSK’s antibody–drug conjugate Blenrep for a narrower set of multiple myeloma patients and regimens than the company requested. The agency’s decision allows Blenrep back onto the U.S. market in specific third‑line settings and in combination with particular agents, while rejecting other combinations. GSK described the clearance as a significant milestone after the drug’s earlier withdrawal in 2022; the approval follows registrational trials that showed benefit in select combinations. The approval underscores the FDA’s case‑by‑case review approach for oncology drugs with safety considerations.
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