FDA has requested that GSK plc (LSE/NYSE:GSK) withdraw the relapsed and refractory multiple myeloma drug Blenrep (belantamab mandolin-blmf) from the U.S. market.
GSK announced in a statement that it has initiated the process.
On November 7, the company announced that the drug did not meet its primary endpoint of progression-free survival (PFS) in the Phase 3 DREAMM-3 study. The humanized IgG1κ monoclonal antibody thus did not comply with FDA’s accelerated approval requirements.
In the study, Blenrep was pitted against Bristol Myers Squibb’s (Nasdaq:GILD), Pomalyst (pomalidomide) and dexamethasone.
GSK shares were up about a percentage point to $33.78.
The FDA approval covered patients with relapsed or refractory multiple myeloma treated with at least four earlier therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulator.
FDA notes that Blenrep is a first-in-class treatment.
GSK will …