The U.S. Food and Drug Administration cleared GSK’s antibody‑drug conjugate Blenrep for use in multiple myeloma in a restricted setting, approving the drug only in combination with a Velcade‑based regimen and for patients after at least two prior therapies. The decision ends a prior U.S. market withdrawal and reflects the agency’s selective, case‑by‑case approach to re‑licensing oncology agents with prior safety concerns. Regulators cited trial data showing benefit in the DREAMM‑7 study but declined broader combination uses sought by GSK.
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