GSK to stop selling blood cancer therapy Blenrep in US

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GSK (NYSE:GSK) will stop selling its blood cancer therapy Blenrep in the U.S., dealing the latest blow to the company’s cancer franchisee.

The British pharma giant on Tuesday said it began the process for withdrawal of the U.S. marketing authorization for Blenrep (belantamab mafodotin-blmf) after the request of the U.S. Food and Drug Administration (FDA).

The FDA had requested a confirmatory study to back the accelerated approval of the drug. However, Blenrep did not meet the main goal of progression-free survival in a phase 3 trial, dubbed DREAMM-3, which was designed to show that the medicine was better than the standard of care.

The FDA had given accelerated approval to Blenrep as a monotherapy to treat treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies.

The approval was based on data of overall response rate and duration of response from a trial called DREAMM-2, but was also contingent upon a confirmed clinical benefit from a phase 3 trial.

GSK said that to ensure patients are supported during this time, those already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program will have the option to enroll in a compassionate use program to continue to access treatment.

“We will continue the DREAMM clinical trial programme and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma,” said Chief Medical Officer Sabine Luik.

GSK added that additional trials within the DREAMM trial program will continue. These trials are designed to show the benefit of Blenrep in combination treatment with novel therapies and standard-of-care therapies in earlier lines of therapy and dosing optimization to maintain efficacy while reducing corneal events.

The company expects data from the phase 3 trials — DREAMM-7 and DREAMM-8 — in H1 2023.

Blenrep is the latest setback for GSK following the restricted use of ovarian cancer therapy Zejula in the U.S., earlier this month which was also carried out at the request of the FDA


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