GSK has secured approval in the European Union (EU) for Blenrep combinations to treat adults with relapsed or refractory multiple myeloma.
The therapy received approval for use in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) in patients who had received a minimum of one previous therapy, including lenalidomide.
Go deeper with GlobalData
The approval was supported by efficacy results from the pivotal DREAMM-7 and DREAMM-8 Phase III trials, which demonstrated clinically meaningful improvements in progression-free survival (PFS) for Blenrep combinations compared to standard triplet therapies in both studies.
In DREAMM-7, Blenrep combinations also showed improved overall survival (OS) compared to a daratumumab-based triplet.
The tolerability and profiles of the combinations were consistent with the established profiles of the individual components.
GSK oncology research and development global head and senior vice-president Hesham Abdullah stated: “Today’s approval of Blenrep combinations is a redefining moment for patients with relapsed or refractory multiple myeloma in the EU.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings.”
The combinations also secured approval in relapsed or refractory multiple myeloma in Japan, the UK and other markets, including Switzerland and Canada, based on the findings from DREAMM-8.
Meanwhile, the US Food and Drug Administration (FDA) has extended the review period for the biologics licence application (BLA) submitted by the company for Blenrep combinations for the same indication.
The new Prescription Drug User Fee Act action date is set for 23 October 2025, allowing the FDA additional time to evaluate the supplementary information provided in support of the BLA.
