Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.
The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.
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The FDA's Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug's first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.
The drug, belantamab mafodotin, could become the first approved therapy for multiple myeloma that targets the cell-surface antigen BCMA. The FDA accepted the application for the drug in January.
The company said the DREAMM-2 study of belantamab mafodotin, its antibody-drug conjugate that targets BCMA, showed a median overall survival of nealry 15 months in heavily pretreated patients.
A Cannacord Genuity analyst pointed to BMS' large pipeline of BCMA-targeting therapies and advanced data, particularly for its CAR-T. However, GlaxoSmithKline has also asserted its anti-BCMA drug could be first past the FDA finish line. But does it matter?
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The company anticipates the FDA to rule on the drug, belantamab mafodotin, in the first half of this year. If approved, it would be the first therapy targeting the cell-surface protein BCMA to hit the market. Several other anti-BCMA drugs are also in development.
Without providing details, GlaxoSmithKline said its trial of BCMA-targeting belantamab mafodotin was positive. The company plans to submit for regulatory approvals later this year - potentially ahead of bluebird and Celgene's expected filing next year for the CAR-T bb2121.
On Saturday, the company will present a poster of Phase I trial data for belantamab mafodotin, which targets the same antigen, BCMA, as Amgen bispecific antibody AMG 420 and multiple CAR-T cell therapies in development.