FDA Decision Delay Puts GSK’s Blenrep Comeback on Hold Amid Safety Concerns
SHERIDAN, WYOMING – July 25, 2025 – The U.S. Food and Drug Administration has delayed its decision on GSK’s antibody-drug conjugate Blenrep, postponing the company's market reentry plans for the treatment of relapsed or refractory multiple myeloma. The updated Prescription Drug User Fee Act (PDUFA) target date is now set for October 23, 2025, following the agency's request for additional information.
Originally granted accelerated approval in 2020, Blenrep was withdrawn in 2022 after failing its confirmatory Phase III DREAMM-3 trial. GSK has since mounted a data-driven effort to revive the therapy’s prospects, presenting positive results from subsequent clinical studies. However, the FDA’s decision to extend the review process underscores lingering regulatory hesitation around the drug’s safety and clinical profile.
Regulatory pause reflects unresolved risk-benefit concerns