China Grants Breakthrough Therapy Designation to GSK's Blenrep for Multiple Myeloma
核心洞察
China's NMPA grants Breakthrough Therapy Designation (BTD) to GSK's Blenrep (belantamab mafodotin) combined with BorDex for relapsed or refractory multiple myeloma (搜索).
The BTD aims to expedite the development of treatments for severe diseases with limited options, showing potential for improved patient outcomes.
The designation is based on Phase III DREAMM-7 trial results, demonstrating statistically significant improvements in progression-free survival (PFS).
China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to GSK's Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BorDex) for treating relapsed or refractory multiple myeloma (搜索). This decision aims to accelerate the availability of new treatments for severe conditions where current options are lacking or show limited efficacy.
The BTD was supported by interim results from the Phase III DREAMM-7 trial, a multicenter, open-label, randomized study. The trial compared belantamab mafodotin plus BorDex to daratumumab plus BorDex in patients with relapsed or refractory multiple myeloma (搜索) who had received at least one prior line of therapy and experienced disease progression during or after their most recent treatment. A total of 494 participants were randomized 1:1 to receive either belantamab mafodotin (2.5mg/kg intravenously every three weeks) with BorDex or daratumumab with BorDex.
The DREAMM-7 trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) with belantamab mafodotin plus BorDex compared to daratumumab plus BorDex. At the time of the interim analysis, a positive trend in overall survival (OS) was observed, although it did not reach statistical significance. Follow-up for OS is ongoing.
Secondary Endpoints
The trial also indicated clinically meaningful improvements across other key secondary endpoints, including overall survival (OS), duration of response, and minimal residual disease negativity rate as evaluated by next-generation sequencing. Additional secondary endpoints included overall response rate, safety, and quality of life outcomes.
The safety and tolerability profile of the belantamab mafodotin combination in the DREAMM-7 trial was consistent with the known profiles of the individual agents.
About Belantamab Mafodotin
Belantamab mafodotin is an antibody-drug conjugate consisting of a humanized B-cell maturation antigen (BCMA (搜索)) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker. The drug linker technology is licensed from Seagen, and the monoclonal antibody is produced using Potelligent Technology licensed from BioWa, a member of the Kyowa Kirin Group.
GSK's senior vice-president Hesham Abdullah stated, "Breakthrough therapy designation in China underscores the potential for Blenrep to redefine outcomes for patients with multiple myeloma (搜索) at or after their first relapse. We look forward to continuing to work with the health authority in China and others worldwide to bring Blenrep-based combinations to patients as expeditiously as possible."
Multiple myeloma (搜索) is a growing health concern in China, with approximately 30,000 new cases diagnosed annually. Blenrep is currently approved as a monotherapy in Hong Kong, Israel, and Singapore.