ODAC Votes Against Blenrep (Belantamab Mafodotin) for Relapsed/Refractory Multiple Myeloma Despite Positive Phase III Data

On July 17, GSK provided an update regarding the U.S. FDA.Oncology Drug Advisory Committee(ODAC) Vote Result Information Update. The agency discussed the benefit/risk of BCMA ADC drug Marabrantumab (Blenrep) at the proposed dose and addressed the combination therapy for Relapsed or Refractory Multiple Myeloma (R/R MM).Voted against the proposal。

Previously, the PDUFA date for this marketing application was set for July 23. The FDA will complete its review and consider ODAC's opinions before this final date.

Screenshot source: Corporate official website

Belantamab mafodotin (Mabalantamab) isAn ADC targeting BCMA. The drug's development and market launch journey has faced considerable setbacks, initially inIn August 2020, based on the results of the pivotal Phase II clinical DREAMM-2 study, it was successively approved for marketing by the US FDA and the EU EMA, asMonotherapy for the treatment of adult patients with relapsed/refractory multiple myeloma，Has becomeThe World's First Approved BCMA ADC。

However, in November 2022, GSK announcedDREAMM-3 Study Did Not Meet Its Primary Endpoint of Progression-Free Survival (PFS)EndpointBased on this, GSK voluntarily withdrew the Belantamab mafodotin marketing application in the United States. Subsequently, the EU EMA also withdrew the marketing authorization for Belantamab mafodotin.

After a series of setbacks, GSK did not abandon this project but continued to explore the drug in clinical trials, eventually succeeding in the DREAMM-7 study. This study evaluatedBelantamab mafodotin + Bortezomib + DexamethasoneAndDaratumumab +Bortezomib + DexamethasoneEfficacy and Safety of Combination Therapy in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Treatment.

Thereafter, in the Phase III clinical trial DREAMM-8, researchers further evaluatedBelantamab mafodotin + Pomalidomide + DexamethasoneCombination Therapy withBortezomib + Pomalidomide + DexamethasoneEfficacy and Safety of Combination Therapy in Relapsed/Refractory MM Patients Who Have Previously Received at Least One Line of Treatment

Based on these two studies, GSK submitted a marketing application for Blenrep to global regulatory authorities. In April 2025, the drug was once again...Achieved the world's first batch in the UK, SubsequentIn May, it was also approved in Japan.，Also received a positive opinion from the CHMP for approval in the EU, andIn China, its marketing application was also included in the priority review process earlier.。

This time in the United States,ODAC's recommendations do not necessarily represent the final review conclusion., the FDA may or may not adopt the agency's opinion. However, this vote still had a negative impact on the commercial launch of Blenrep in the United States. GSK stated that it remains confident in the benefit/risk profile of Blenrep and will work closely with the FDA to advance the drug’s approval for marketing.

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