EC Approves BMS Leukemia Drug in Pediatric Combination Therapy

On Feb. 11, 2019, Bristol-Myers Squibb (BMS) announced that it received approval from the European Commission for Sprycel (dasatinib) in combination with chemotherapy for treating pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL), making this the second pediatric leukemia indication for the drug in Europe. The approval includes both the tablet form of Sprycel and the powder for oral suspension (PFOS) formulation of the drug, which is new for pediatric patients with ALL in Europe, according to the company.

With this approval, Sprycel (dasatinib) is now indicated for treating pediatric patients 1 year of age and older with Ph+ chronic myeloid leukemia (CML) in chronic phase and newly diagnosed Ph+ ALL in combination with chemotherapy as well as adults with newly diagnosed Ph+ CML in chronic phase; chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML; and Ph+ ALL with resistance or intolerance to prior therapy.

“We are proud that the approval by the European Commission brings children with Ph+ acute lymphoblastic leukemia a new treatment option, including a powder formulation developed as part of our commitment to addressing the unique needs of children with cancer,” said Fouad Namouni, MD, head, oncology development, Bristol-Myers Squibb, in a company press release.