GSK application for myeloma treatment accepted by EMA

19th Jul 2024 12:33

(Sharecast News) - GSK announced on Friday that the European Medicines Agency (EMA) has accepted its marketing authorisation application for 'Blenrep', or belantamab mafodotin, in combination with bortezomib plus dexamethasone - 'BorDex', or pomalidomide plus dexamethasone - PomDex, for treating relapsed or refractory multiple myeloma.

The FTSE 100 pharmaceutical giant said the EMA's Committee for Medicinal Products for Human Use (CHMP) would now begin the formal review process to recommend potential authorisation to the European Commission.

It said the application was supported by interim results from the phase three 'DREAMM-7' and 'DREAMM-8' trials, both of which achieved their primary endpoints by demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the Blenrep combinations compared to standard care treatments.

Specifically, the DREAMM-7 trial compared Blenrep combined with BorDex against daratumumab plus BorDex, while the DREAMM-8 trial evaluated Blenrep with PomDex versus bortezomib plus PomDex.

Although the trials also indicated a positive trend in overall survival (OS), GSK said that was not statistically significant at the interim analysis stage, with overall survival follow-up ongoing.

Additionally, the results showed clinically meaningful improvements across all secondary efficacy endpoints, including deeper and more durable responses compared to the standard care combinations.

The safety and tolerability profiles observed for the Blenrep combinations were consistent with the known profiles of the individual agents involved in the trials.

"Today's milestone reinforces the potential for Blenrep to redefine outcomes for patients with multiple myeloma at or after first relapse," said senior vice-president and global head of oncology research and development Hesham Abdullah.

"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 three head-to-head trials."

At 1214 BST, shares in GSK were down 0.81% at 1,517.62p.

Reporting by Josh White for Sharecast.com.