GSK (LON: GSK) shares are up slightly on Tuesday after the company revealed it has begun the process to withdraw US marketing authorisation for Blenrep after a request of the US Food and Drug Administration (FDA).
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The FDA request was due to the outcome of the company’s DREAMM-3 phase III confirmatory trial, which didn’t meet the US FDA Accelerated Approval regulations requirements. The trial results were previously announced.
Blenrep is GSK’s potential monotherapy treatment for adults with relapsed or refractory multiple myeloma (RRMM).
Despite the trial results, the company said it still believes, based on the totality of data, that the benefit-risk profile of Blenrep is still “favourable.”
“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 Sabine Luik, GSK’s Chief Medical Officer.
“Additional trials within the DREAMM clinical trial programme are designed to determine the benefit of belantamab mafodotin-blmf in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy and dosing optimisation to maintain efficacy while reducing corneal events,” added Luik. “Data from the DREAMM-7 and DREAMM-8 phase III trials are event-driven, and results are anticipated in the first half of 2023. The results of these trials will be shared with health authorities and inform future regulatory pathways.”
GSK’s London-listed shares are up 0.2% at the time of writing. However, in 2022, the stock has declined by over 12%.