The U.S. Food and Drug Administration cleared GSK’s BCMA-targeting antibody–drug conjugate Blenrep for use in multiple myeloma under a narrowed approval: the agency authorized Blenrep in combination with a specific Velcade-containing regimen for patients who have had at least two prior lines of therapy, but rejected another combination GSK had pursued. The decision follows a turbulent post-approval history that included a 2022 withdrawal after a failed confirmatory trial and subsequent re-evaluation through DREAMM program data. GSK framed the approval as an important milestone, citing DREAMM‑7 results where a Blenrep–Velcade regimen halved the risk of death and extended progression‑free survival versus a standard three‑drug comparator. The FDA’s split decision reflects residual concerns over ophthalmic toxicity and benefit–risk tradeoffs raised by advisers and agency reviewers; the agency accepted DREAMM‑7 data but declined the DREAMM‑8 regimen the company requested. Investors and clinicians will parse the label language and dosing restrictions closely; the outcome illustrates the FDA’s case‑by‑case approach for complex oncology agents with mixed confirmatory data. GSK now faces the commercial task of relaunching a previously withdrawn BCMA therapy in the U.S. amid a crowded BCMA therapeutic landscape.