GSK nabs FDA approval for first-in-class multiple myeloma drug

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 Food and Drug Administration has granted accelerated approval to a drug for multiple myeloma that is the first of its kind.

London-based GlaxoSmithKline said Thursday that the FDA had approved the drug Blenrep (belantamab mafodotin-blmf) in patients who have received at least four prior lines of therapy for multiple myeloma, which is the second most common blood cancer in the world. The drug is the first approved treatment that targets the antigen BCMA.

Shares of GSK were down nearly 1.5% on the London Stock Exchange when the market closed.

The decision comes a little over three weeks after the FDA’s Oncology Drugs Advisory Committee voted unanimously that Blenrep’s clinical trial data supported approval. The July 14 vote was in spite of concerns that the FDA had expressed about the drug in briefing documents posted ahead of the AdCom meeting, particularly with regard to ocular toxicity, which led to skepticism about its risk-benefit profile. The drug is an antibody-drug conjugate, which consists of a monoclonal antibody targeting BCMA with a cytotoxic pharmaceutical agent attached via a linker.

The drug’s prescribing information includes a boxed warning for ocular toxicity, particularly dry eyes and blurred vision, resulting from changes to the corneal epithelium.

Blenrep is only the first of numerous multiple myeloma therapies in development that target BCMA, an antigen widely expressed in the disease. The next product most likely to win approval is bluebird bio and Bristol-Myers Squibb’s CAR-T cell therapy idecabtagene vicleucel, which nevertheless hit a speed bump in May when the FDA responded to their approval application with a refuse-to-file letter that requested additional documentation related to chemistry, manufacturing and controls. The companies refiled their approval application for the CAR-T last week.

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