Myeloma Drug's Comeback Nixed by FDA Panel

Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel

The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have become more difficult after the negative advisory committee vote.

GSK's growth plans dented by Blenrep setback

FDA advisors have voted that the benefit/risk profile of GSK's multiple myeloma therapy, Blenrep, does not support its approval in the US.

Myeloma Drug's Comeback Nixed by FDA Panel

(MedPage Today) -- The comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee (ODAC) voted that the drug does not have a favorable benefit-risk profile in combination with either...

US FDA rejects GSK's blood cancer drug over safety, limited treatment benefit

GSK’s attempt to relaunch Blenrep was blocked by FDA advisers due to poor clinical benefit, safety concerns, and eye-related side effects.

FDA advisers vote against combination therapies of GSK’s blood cancer drug

(Reuters) -The U.S. Food and Drug Administration’s panel of independent advisers voted on Thursday against approval of GSK’s blood cancer drug Blenrep for use in combination with other treatments. The panel voted 5-3 against approving Blenrep in combination with bortezomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have undergone at least one prior therapy. Multiple myeloma, the third most common type o…

GSK’s Blood Cancer Drug Blenrep Fails to Win FDA Panel Support

GSK Plc’s blood cancer drug failed to secure the backing of a panel of US regulatory advisers, putting its approval in doubt.