GSK's Blood Cancer Drug Faces US Setback Due To FDA Panel's Eye Safety Warning

The U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s (NYSE:GSK) Blenrep (belantamab mafodotin-blmf) combinations.

The belantamab mafodotin combinations were evaluated in adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy.

The FDA will consider the committee’s recommendation as it finalises its review on Blenrep ahead of the 23 July 2025 PDUFA date. 

Also Read: UK Becomes First Country To Authorize Blenrep In Two Combo Regimens

Multiple myeloma is the third most common blood cancer globally and is generally considered treatable but not curable. There are approximately more than 180,000 new cases of multiple myeloma diagnosed globally each year.

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.

Ahead of the meeting, ...