After Disappointing Confirmatory Study, GSK To Withdraw Approved Blood Cancer Drug In US

GSK plc GSK has initiated the withdrawal process of the U.S. marketing authorization for Blenrep (belantamab mafodotin-blmf) following the FDA request.
This request was based on the previously announced outcome of the DREAMM-3 Phase 3 confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.
Also see: Citing Efficacy, GSK Stops Two Pivotal UTI Antibiotic Trials Early.
Patients already enrolled in the Blenrep Risk Evaluation, and Mitigation Strategy program will have the option to enroll in a compassionate use program to continue to access treatment.
Additional trials within the DREAMM clinical trial program are designed to determine the benefit of belantamab mafodotin in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimization to maintain efficacy while reducing corneal events.
Data from the DREAMM-7 and DREAMM-8 phase 3 trials are event-driven, and results are anticipated in the first half of 2023.
Price Action: GSK shares are up 0.45% at $33.59 during the premarket session on the last check Tuesday.