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The FDA has approved GSK’s Blenrep as a third-line multiple myeloma drug, overcoming a negative advisory committee vote and clearing the way for a relaunch in the US.
The approval comes after a three-month review delay from the FDA and two negative votes from the agency’s Oncologic Drugs Advisory Committee for the drug as an earlier line of therapy. Blenrep was pulled from the market in 2022 after a failed confirmatory trial.
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