FDA approves new indication for leukemia drug Blincyto

The US Food and Drug Administration on Friday granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD).

The FDA granted this application from US biotech major Amgen (Nasdaq: AMGN) priority review and it received orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

"This is the first FDA-approved treatment for patients with MRD-positive ALL," commented Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Because patients who have MRD are more likely to relapse, having a treatment option that eliminates even very low amounts of residual leukaemia cells may help keep the cancer in remission longer," he added.