The U.S. Food and Drug Administration approved GSK’s antibody–drug conjugate Blenrep for a narrowed multiple myeloma indication after a complex regulatory review. The agency cleared Blenrep for use in patients with relapsed or refractory multiple myeloma after at least two prior lines of therapy and authorized one combination regimen but rejected another, reflecting a split assessment of the drug’s benefit–risk profile. GSK called the decision a significant milestone in returning Blenrep to the U.S. market after a 2022 withdrawal, citing positive DREAMM-7 durability and survival data. The approval underscores the FDA’s case‑by‑case posture on oncology approvals where safety signals and comparative data vary across regimens.