FDA Raises Concerns Over GSK’s Blenrep as Multiple Myeloma Reapproval Hangs in the Balance
SHERIDAN, WYOMING – July 25, 2025 – The U.S. Food and Drug Administration (FDA) has cast doubt over GSK’s attempt to return its antibody-drug conjugate Blenrep to the U.S. market for relapsed or refractory multiple myeloma, citing persistent safety concerns and limited evidence of efficacy across key patient populations.
Once granted accelerated approval in August 2020, Blenrep was withdrawn in late 2022 after failing to demonstrate a progression-free survival (PFS) benefit in the DREAMM-3 confirmatory trial. Although GSK has since presented new clinical data from two subsequent Phase III studies—DREAMM-7 and DREAMM-8—the FDA has expressed skepticism about the drug’s overall benefit-risk profile.
Efficacy Gains Shadowed by Ocular Toxicity and Dosing Issues