GSK’s application for Blenrep for MM treatment accepted for EMA review

Betsy Goodfellow | July 19, 2024 | News story | Medical Communications |  Blenrep, EMA, GSK, Oncology 

GSK has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for Blenrep (belantamab mafodotin) in combination with bortezombin plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) as a treatment for relapsed or refractory (R/R) multiple myeloma (MM).

The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to begin the formal review process imminently, before making a recommendation to the European Commission (EC) regarding the drug’s potential authorisation.

The application follows interim results from the DREAMM-7 and DREAMM-8 phase 3 trials, both of which met their primary endpoints and showed statistically significant and clinically meaningful improvements in progression free survival (PFS) for the Blenrep combinations compared to standard of care combinations in this indication.

The DREAMM-7 trial is currently assessing Blenrep with BorDex compared to daratumumab plus BorDex, and the DREAMM-8 trial continues to evaluate Blenrep with PomDex compared to bortezomib with PomDex.

Positive overall survival (OS) data has been observed in both trials, however it was not statistically significant at the point of this interim analysis.

Hesham Abdullah, senior vice president and global head oncology of R&D at GSK, commented: “Today’s milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse. We are working to bring Blenrep to patients as quickly as possible given the high unmet need and the clinically robust effects of the Blenrep combinations in the DREAMM-7 and DREAMM-8 phase 3 head-to-head trials.”

Betsy Goodfellow