FX.co ★ GSK: Japan Accepts For Review NDA For Blenrep Combinations In Relapsed/refractory Multiple Myeloma

GSK plc (GSK, GSK.L) announced on Tuesday that regulatory review for Blenrep (belantamab mafodotin) in combination therapies for relapsed/refractory multiple myeloma has been accepted in Japan.

Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted a new drug application (NDA) for Blenrep in combination with either bortezomib plus dexamethasone (BorDex) or pomalidomide plus dexamethasone (PomDex) for the treatment of relapsed or refractory multiple myeloma.

Additionally, the MHLW has granted orphan drug designation for Blenrep, ensuring priority review for this therapy in the context of multiple myeloma, which is the third most common blood cancer globally and is typically considered treatable but not curable.

GSK based its application on interim results from the DREAMM-7 and DREAMM-8 phase III trials. Both trials achieved their primary endpoints, demonstrating statistically significant and clinically meaningful improvements in progression-free survival for the Blenrep combinations compared to standard of care combinations in patients with relapsed or refractory multiple myeloma.

The DREAMM-7 trial is evaluating the combination of belantamab mafodotin with BorDex against daratumumab plus BorDex. Meanwhile, the DREAMM-8 trial is assessing belantamab mafodotin combined with PomDex in comparison to bortezomib plus PomDex.

Although both trials showed a positive overall survival (OS) trend, it was not statistically significant at the time of interim analysis. Follow-up for overall survival continues.

This acceptance marks the third major regulatory filing for belantamab mafodotin combinations in managing relapsed/refractory multiple myeloma. Earlier, the European Medicines Agency accepted a marketing authorization application in July 2024, and the UK's Medicines and Healthcare products Regulatory Agency gave its acceptance earlier this month.

The DREAMM-7 trial results were initially disclosed at the American Society of Clinical Oncology (ASCO) Plenary Series in February 2024, followed by an encore at the ASCO Annual Meeting, with findings published in the New England Journal of Medicine. DREAMM-8 results were first presented at the 2024 ASCO Annual Meeting and subsequently published in the New England Journal of Medicine.

Hesham Abdullah, Senior Vice President and Global Head of Oncology R&D at GSK, stated, "The Blenrep combinations have shown promising potential based on the results of the DREAMM-7 and DREAMM-8 trials to change how we treat relapsed/refractory multiple myeloma. We are dedicated to collaborating with health authorities worldwide to expedite the regulatory process and provide these additional treatment options to patients as swiftly as possible."