Why GSK is pulling multiple myeloma drug Blenrep from U.S. market

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 …

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