FDA OKs Expanded Sprycel Indication

FDA has approved an expanded indication for Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) tablets to include treating pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Approval is based on data from the Phase 2 study, CA180-372, which at three years demonstrated an event-free survival binary rate of 64.1%. Event-free survival is defined as the time from starting Sprycel to lack of complete response at the end of the third high-risk block, relapse, secondary malignancy or death from any cause, according to the company.

BMS says that of the 81 patients evaluated for safety, fatal adverse reactions occurred in three (4%), and eight (10%) experienced adverse reactions leading to treatment discontinuation, including fungal sepsis, hepatotoxicity of graft versus host disease, thrombocytopenia, CMV infection, pneumonia, nausea, enteritis and drug hypersensitivity.