The FDA approved GSK’s antibody‑drug conjugate Blenrep for a restricted multiple myeloma indication after a three‑year market withdrawal, authorizing its use in combination with a Velcade‑based regimen but not with Pomalyst. The agency limited approval to patients who have received at least two prior lines of therapy, narrower than GSK’s request. Blenrep, a BCMA‑targeting ADC previously withdrawn after failed confirmatory trials and ocular toxicity concerns, received the new U.S. clearance based on DREAMM‑7 data showing survival and progression‑free survival benefits when paired with Velcade. GSK called the decision a "significant milestone," noting an ongoing need for novel myeloma options. Regulatory advisors and the FDA previously flagged dosing and toxicity; the split decision reflects the agency’s case‑by‑case approach to complex benefit‑risk profiles in oncology approvals. The ruling lets GSK relaunch Blenrep selectively while keeping restrictions tied to regimen and line of therapy.