Blenrep combo accepted for priority review in China in relapsed/refractory multiple myeloma: GSK
London: GSK plc has announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BVd) as a treatment for relapsed or refractory multiple myeloma.
Earlier this year, the NMPA granted priority review for this application as well as Breakthrough Therapy Designation1 for the BVd combination, which is intended to expedite development of investigational drugs with potential for substantial improvement over available therapies.
Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, “The regulatory filing acceptance, with a priority review, is a meaningful step forward in our efforts to bring the benefits of Blenrep in combination to patients in China. Multiple myeloma patients need new options that may improve outcomes, particularly at first relapse. The DREAMM-7 trial shows statistically significant efficacy, including overall survival and could redefine treatment in this patient population.”
This is the seventh major regulatory filing acceptance this year for belantamab mafodotin in combination for the treatment of relapsed or refractory multiple myeloma based on the results of the DREAMM-7 and DREAMM-8 trials. In 2024, belantamab mafodotin combinations have been accepted for review in the US, European Union, Japan (with priority review), United Kingdom, Canada and Switzerland (with priority review for DREAMM-8).
The application is based on the interim results of the phase III head-to-head DREAMM-7 trial, which met its primary endpoint, showing statistically significant and clinically meaningful improvement in progression-free survival (PFS) for BVd compared to daratumumab plus bortezomib and dexamethasone (DVd) in relapsed or refractory multiple myeloma. In a subsequent planned interim analysis, the DREAMM-7 trial met the key secondary endpoint of overall survival (OS), showing that BVd significantly reduced the risk of death versus standard of care DVd.
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