Amgen Wins U.S. Approval for Drug to Treat Rare Leukemia
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Amgen Inc. won early U.S. approval for a drug that uses patients’ own immune systems to fight a rare form of leukemia as regulators seek to move quicker to provide potential treatments for unmet medical needs.
The Food and Drug Administration cleared the immunotherapy, to be marketed as Blincyto, for patients with a form of acute lymphoblastic leukemia. The medicine was approved five months ahead of schedule after being designated a breakthrough therapy, which allowed Thousand Oaks, California-based Amgen additional access to FDA staff members to guide the drug through its review, the agency said yesterday in a statement.