The FDA oncologic drugs advisory committee voted against the approval of GSK’s blood cancer treatment Blenrep, delivering a setback to the drugmaker’s efforts to reintroduce the drug to the U.S. market, The Wall Street Journal reported July 17.
The FDA’s Oncologic Drugs Advisory Committee voted July 17 after evaluating Blenrep in combination therapies for adults with relapsed or refractory myeloma who received at least one previous treatment.
The drug showed positive overall survival data in a late-stage trial, GSK said in December. The drugmaker withdrew the drug from the U.S. market in 2022 after a clinical trial showed it did not outperform an existing treatment when used alone.
The FDA is expected to make a final decision on Blenrep’s approval by July 23, according to the Journal.
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