GSK: Japan Accepts For Review NDA For Blenrep Combinations In Relapsed/refractory Multiple Myeloma

(RTTNews) - Drug maker GSK plc (GSK, GSK.L) announced Tuesday that Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple myeloma have been accepted for regulatory review in Japan.

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

MHLW also has granted orphan drug designation for Blenrep, which ensures priority NDA review in multiple myeloma, the third most common blood cancer globally, which is generally considered treatable but not curable.

GSK noted that the application was based on interim results from the DREAMM-7 and DREAMM-8 phase III trials, which both met their primary endpoints, showing statistically significant and clinically meaningful improvements in progression-free survival for the belantamab mafodotin combinations compared to standard of care combinations in relapsed or refractory multiple myeloma.

The DREAMM-7 trial is evaluating belantamab mafodotin combined with BorDex versus daratumumab plus BorDex, while the DREAMM-8 trial is evaluating belantamab mafodotin in combination with PomDex versus bortezomib plus PomDex.

Meanwhile, a positive overall survival or OS trend was observed in both trials but was not statistically significant at the time of interim analysis. Follow-up for OS continues.

GSK noted that this is the third major regulatory filing acceptance for belantamab mafodotin combinations in the treatment of relapsed/refractory multiple myeloma. Earlier, marketing authorisation application was accepted by the European Medicines Agency in July 2024 and by the Medicines and Healthcare products Regulatory Agency in the UK earlier this month.

Results from DREAMM-7 were first presented at the American Society of Clinical Oncology Plenary Series in February 2024, shared in an encore presentation at the 2024 ASCO Annual Meeting, and published in the New England Journal of Medicine.

Results from DREAMM-8 were first presented at the 2024 ASCO Annual Meeting and published in the New England Journal of Medicine.

Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said, "Blenrep combinations show potential based on the results of the DREAMM-7 and DREAMM-8 trials to redefine the treatment of relapsed/refractory multiple myeloma. We are committed to working with health authorities worldwide to advance Blenrep along regulatory pathways so we can bring these additional treatment options to patients as quickly as possible."

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