GSK's Blenrep treatment accepted for review by FDA

The US Food and Drug Administration has accepted for review a Biologics License Application for Blenrep, otherwise known as belantamab mafodotin, in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]).

The news follows GSK's DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival compared with standard care.

This is the sixth major regulatory filing acceptance this year for Blenrep combinations in the treatment of relapsed/refractory multiple myeloma based on the results of the trials. Blenrep has already been accepted for review in the EU, Japan, UK, Canada and Switzerland, while China has expedited the development of the treatment via the grant of a Breakthrough Therapy Designation.

"Relapsed/refractory multiple myeloma treatment could be transformed by additional, efficacious treatment options with manageable side effects and community-based administration," said Hesham Abdullah, senior vice president and global head of oncology at GSK's R&D division. "We look forward to working with the FDA on this review."

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