US FDA Withdrawals | News | Blenrep was withdrawn from the US market | iPharmaCenter

November 22, 2022

Blenrep was withdrawn from the US as it did not show superiority over PomDex in patients with RRMM.

GSK announced that it had initiated the withdrawal application of Blenrep (belantamab mafodotin) following the US Food and Drug Administration (FDA) request.

Blenrep was approved for adults with relapsed or refractory multiple myeloma who were previously treated with four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

The request was based on Phase 3 DREAMM-3 trial, in which Blenrep failed to show superiority over pomalidomide plus low-dose dexamethasone. The primary endpoint is progression-free survival; the median PFS was 11.2 months in Blenrep versus seven months in patients on PomDex. The overall response rate (ORR) was 46% versus 36%; the median duration of response was not met in the Blenrep arm versus 8.5 months in patients on PomDex. The median OS was 21.2 months in the Blenrep arm versus 21.1 months in patients on PomDex.

Blenrep is an antibody-drug conjugate, a conjugate between BCMA monoclonal antibody cytotoxic agent auristatin F via a non-cleavage linker.