The FDA has approved GSK’s antibody‑drug conjugate Blenrep for a limited multiple myeloma indication after the drug failed a prior confirmatory trial and was pulled in 2022. The agency cleared Blenrep in a restricted setting—use with a specific Velcade-containing regimen for patients who have received at least two prior lines—rather than the broader label GSK sought. GSK said the decision completes a regulatory turnaround following DREAMM‑7 and related studies that drove approvals in Europe and Japan. FDA briefing materials and advisory committee debate highlighted ocular toxicity concerns and delimited benefit‑risk data, leading to the agency’s more targeted approval.