New indication for Sprycel sought by B-MS

Some 12 years after the drug’s first US Food and Drug Administration (FDA) approval in leukemia, Bristol-Myers Squibb (NYSE: BMY) is still targeting new patients with Sprycel (dasatinib).

The US pharma major has had its supplemental Biologics License Application (sBLA) accepted by the FDA for the drug’s usage in combination with chemotherapy for the treatment of pediatric patients with newly-diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

A decision will be made on whether to approve the sBLA, which is based on an ongoing Phase II trial, by the end of this year.