FDA advisors spurn GSK’s Blenrep comeback dreams on safety, trial concerns

CAR-T Digest - August 2020

17 July 2025: FDA advisors spurn GSK’s Blenrep comeback dreams on safety, trial concerns

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted against GSK’s efforts to reintroduce its multiple myeloma ADC, Blenrep, in combination therapies due to serious safety concerns, especially high rates of ocular toxicity and unresolved dosage optimization
ODAC members raised issues about the design of GSK’s pivotal DREAMM-7 and DREAMM-8 trials, particularly the very low U.S. patient enrollment (under 5%), which limited confidence in assessing the drug’s benefit-risk profile for the proposed U.S. population
GSK faces a major regulatory hurdle ahead of the FDA’s final decision due by July 23. Blenrep was previously withdrawn globally in 2022 after failing a confirmatory trial despite prior FDA approval as a monotherapy