GSK Announces New Drug Application for Blenrep in Combination with Bortezomib
Wednesday, September 18, 2024
GSK has announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted a new drug application (NDA) for Blenrep (belantamab mafodotin) in combination with either bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) for treating relapsed or refractory multiple myeloma.
Multiple myeloma has become a growing health concern in Japan, where diagnoses have steadily increased over the past five decades.
DREAMM-7 is investigating Blenrep in combination with BorDex, while DREAMM-8 is studying its use alongside PomDex. Both trials showed improved secondary efficacy endpoints, including more durable responses compared to the current standard treatments. The safety profile of Blenrep was consistent with that of the individual agents in the trials.
Blenrep is a monoclonal antibody-drug conjugate targeting B-cell maturation antigen, linked to a cytotoxic agent via a non-cleavable linker.
It is currently approved as a monotherapy in Hong Kong, Israel, and Singapore. Further trial results, including those involving Japanese patients, are expected to be presented at future scientific meetings.
Additionally, Blenrep has been granted orphan drug designation in Japan, ensuring priority review due to the high unmet medical need in this area.
This is the third regulatory submission for Blenrep in combination therapy for multiple myeloma, following similar applications to the European Medicines Agency (EMA) in July 2024 and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) earlier this month.
The submission is supported by interim results from the DREAMM-7 and DREAMM-8 phase III trials, both of which demonstrated statistically significant improvements in progression-free survival (PFS) when compared to current standard treatment combinations.
Although an overall survival (OS) benefit was observed, it was not statistically significant at the interim analysis, and follow-up for OS continues.
Source: gsk.com
