Saturday, February 8, 2025

Multiple Myeloma: Blenrep Combinations Under Review by European Medicines Agency

Similar articles

Multiple myeloma treatments may soon see a significant advancement as the European Medicines Agency (EMA) has accepted the marketing authorization application for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex). GSK plc (LSE/NYSE: GSK) announced that this submission is supported by positive data from the phase III DREAMM-7 and DREAMM-8 trials. These trials showed a notable progression-free survival benefit and positive overall survival trends for the Blenrep combinations compared to the standard of care. If approved, these combinations could potentially redefine the treatment landscape for relapsed or refractory multiple myeloma.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, highlighted the significance of this milestone, stating, “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 III head-to-head trials.”

Subscribe Weekly Market Access News

* indicates required

Multiple Myeloma Treatment Advancements with Blenrep

The regulatory submission for Blenrep is based on interim results from the DREAMM-7 and DREAMM-8 phase III trials. Both trials successfully met their primary endpoints, demonstrating statistically significant and clinically meaningful improvements in progression-free survival (PFS) for the belantamab mafodotin combinations compared to standard of care treatments in patients with relapsed or refractory multiple myeloma. Specifically, the DREAMM-7 trial compared belantamab mafodotin combined with BorDex against daratumumab plus BorDex, while the DREAMM-8 trial evaluated belantamab mafodotin combined with PomDex versus bortezomib plus PomDex.

In addition to PFS benefits, both trials indicated a positive overall survival (OS) trend, though this was not statistically significant at the interim analysis stage. Ongoing follow-up for OS continues, and the trials also showed clinically meaningful improvements across all other secondary efficacy endpoints.

Multiple Myeloma

Multiple Myeloma: Positive Trends in Overall Survival and Efficacy

These improvements included deeper and more durable responses compared to the standard of care combinations. The safety and tolerability profiles of the belantamab mafodotin combinations in the DREAMM-7 and DREAMM-8 trials were consistent with the known profiles of the individual agents.

The acceptance of the marketing authorization application by the EMA’s Committee for Medicinal Products for Human Use (CHMP) is a significant step. The CHMP will now begin a formal review process to make a recommendation to the European Commission regarding the potential authorization of Blenrep in these combinations. This development could offer new hope for patients suffering from multiple myeloma, providing a novel treatment option that has demonstrated substantial benefits in clinical trials.

Overall, this advancement underscores GSK’s commitment to addressing the unmet needs in the treatment of multiple myeloma. The results from the DREAMM-7 and DREAMM-8 trials provide strong evidence supporting the efficacy of Blenrep combinations, which could soon become a vital part of multiple myeloma treatment protocols pending regulatory approval.

Resource: Glaxo Smith Kline, July 19, 2024

You can follow our news on our Telegram, LinkedIn and Youtube accounts.


This article has been prepared with the assistance of AI and reviewed by an editor. For more details, please refer to our Terms and Conditions. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author.

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article