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

  • GSK plc (NYSE: 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.

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