An expert panel advising the US drug regulator has voted against GSK PLC's (LSE:GSK, NYSE:GSK) Blenrep drug combinations for patients with relapsed or refractory multiple myeloma.
The US Food and Drug Administration's oncologic drugs advisory committee voted against the overall benefit/risk profile of belantamab mafodotin-blmf based on the proposed dosage used in clinical studies.
GSK said the FDA will consider the panel’s recommendation ahead of the 23 July 2025 Prescription Drug User Fee Act (PDUFA) date, when the regulator decides on new drug approval.
The FTSE 100 drugmaker said: "GSK remains confident in the benefit/risk profile of Blenrep (belantamab mafodotin-blmf) and will continue to work closely with the FDA as they complete their review for Blenrep in patients with relapsed or refractory multiple myeloma where there is high unmet need for novel treatment options that extend survival."
Blenrep combinations are already approved in the UK, Japan, and several other markets based on results from the DREAMM-7 and DREAMM-8 phase III trials.
Applications are under review in additional markets, including the European Union and China.