Research & Development
GSK to withdraw Blenrep in US market after failed trial
22 November 2022 -

GSK plc (LSE: GSK) (NYSE: GSK) is to withdraw its blood cancer drug Blenrep (belantamab mafodotin-blmf) from the US market, the biopharmaceutical company announced on Tuesday.

This decision comes after a Phase 3 trial of Blenrep did not meet the requirements of the US Food and Drug Administration (FDA) Accelerated Approval regulations.

Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

GSK said that it continues to believe, based on the totality of data available from the development programme, that the benefit-risk profile of belantamab mafodotin-blmf remains favourable in this hard-to-treat patient population. Patients responding to belantamab mafodotin-blmf experienced durable clinical benefit, and safety remains consistent with the known safety profile, the company added.

Following a request by the FDA, GSK has initiated the process for withdrawal of the US marketing authorisation for Blenrep.

Sabine Luik, chief medical officer, said that the company will continue the clinical trial programme and work with the US regulator "on a path forward for this important treatment option for patients with multiple myeloma".



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