Sprycel Market, By Application (Chronic myeloid leukemia (CML), Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia), By Age Group (Adult Patients, Pediatric Patients), By Distribution Channel: (etail Pharmacies, Online Pharmacies and Specialty Pharmacies), By Region (North America, Europe, Asia Pacific, Latin America, Middle East, and Africa)
In February 2019, Bristol-Myers Squibb Company announced that the European Commission (EC) has approved Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). This is the second pediatric leukemia indication for Sprycel in Europe. The approval includes both the tablet form of Sprycel and, in a first for pediatric patients with ALL in Europe, the powder for oral suspension (PFOS) formulation of Sprycel.
In January 2019, Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has expanded the indication for Sprycel (dasatinib) tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy. Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population. The approval, which was granted following priority review by the U. FDA, is based on data from the Phase 2 study, CA180-372 (NCT01460160).