GSK said Thursday its cancer drug Blenrep won U.S. approval to treat adults with multiple myeloma that has returned or stopped responding to treatment, overcoming an earlier negative recommendation from a regulatory advisory panel.
The Food and Drug Administration approved the drug in combination with two other therapies for patients who have received at least two prior lines of treatment.
The decision follows a vote in July where an FDA advisory committee concluded the drug's benefits did not outweigh its risks at the proposed dosage.
According to the company, the approval was supported by data from a late-stage trial where the Blenrep combination reduced the risk of death by 51% and tripled the time patients lived without their disease worsening to 31.3 months, compared to a standard treatment.
"Today's FDA approval of Blenrep is another significant milestone, providing potential for superior efficacy, including overall survival, to US patients," said Tony Wood, GSK's Chief Scientific Officer.
The company noted that the drug can be administered in community centers, where it says 70% of patients receive care.
The treatment is already approved for similar uses in the European Union, the UK, and Japan.
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