Glaxo Blood Cancer Treatment Wins Backing From FDA Committee
(Bloomberg) -- GlaxoSmithKline Plc took a step forward in its bid for U.S. approval of a novel blood cancer drug, after a panel advising the Food and Drug Administration voted in favor of its use.
The panel voted 12-0 Tuesday for belantamab mafodotin, used to treat multiple myeloma, after hearing evidence the drug affected some patients’ vision, the company said in an email. The Oncologic Drugs Advisory Committee decided the benefits outweighed the risks. Glaxo rose as much as 1.7% in London trading.
The drug is one of three cancer treatments that Glaxo hopes will be cleared this year as the British pharmaceutical giant makes a push to build out its oncology pipeline. The company won U.S. approval for ovarian cancer drug Zejula for use at an earlier stage of treatment in April and is seeking the go-ahead for an endometrial cancer drug by year-end.
The myeloma drug’s annual sales could peak at $1.5 billion, according to analysts at Jefferies, who are skeptical about its expanded use in earlier lines of therapy. “Not all patients will be willing to accept the ocular toxicity concerns, and we see potential downside risk,” they wrote in a note.
Clinical trials of the myeloma drug affected vision in 17% of patients, with impacts including corneal degeneration. The company has said the treatment, if approved, would become the first to target a protein called BCMA.
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