Amgen wins US approval for drug to treat rare leukemia

WASHINGTON: Amgen Inc. (AMGN) 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.

The medicine is part of a class in one of the hottest areas of cancer research, known as immunotherapy because it stimulates patients' immune systems to work more effectively against the disease. Clinical trials on immunotherapies have shown the drugs may have a significant benefit for a minority of patients. Companies such as Merck & Co. (MRK), Bristol-Myers Squibb Co., AstraZeneca Plc (AZN) and Roche Holding AG began at least 78 clinical trials on such drugs last year.

"Immunotherapies, especially Blincyto with its unique mechanism of action, are particularly promising for patients with leukemia," Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in the statement. "Recognizing the potential of this novel therapy, the FDA worked proactively with the sponsor under our breakthrough therapy designation program to facilitate the approval of this novel agent." The FDA approved another immunotherapy in September, Keytruda from Merck to treat advanced melanoma, two months before the agency was scheduled to make a decision. Keytruda is also designated as a breakthrough therapy.