The FDA granted a constrained approval for GSK’s BCMA‑targeting ADC Blenrep, allowing its use in patients with relapsed or refractory multiple myeloma after at least two prior lines of therapy and in one combination regimen but denying another. The agency approved Blenrep with Velcade (bortezomib) based on DREAMM‑7 data showing halved mortality risk and improved progression‑free survival, while declining approval in the Pomalyst combination. The decision completes a U.S. relaunch three years after Blenrep’s withdrawal following a confirmatory failure, and underscores the FDA’s case‑by‑case assessment of benefit‑risk in oncology approvals.
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