FDA Grants Priority Review to New Indications of Dasatinib for CML
The US Food and Drug Administration agreed to a priority review of a supplemental New Drug Application for dasatinib for CML.
The US Food and Drug Administration (FDA) agreed to a priority review of a supplemental New Drug Application (sNDA) for dasatinib, according to a press release.1 The application is for potential new indications of dasatinib for pediatric patients with Philadelphia chromosome–positive (Ph+) chronic phase chronic myeloid leukemia (CP-CML), as well as a powder for oral suspension formulation of dasatinib.1
Dasatinib, a tyrosine kinase inhibitor (TKI), is indicated for adult patients with newly diagnosed, Ph+ CML, adults with Ph+ CP CML resistant or intolerant to prior therapy, and adults with Ph+ acute lymphoblastic leukemia (ALL) with intolerance or resistance to prior therapy.
The FDA granted priority review to this sNDA based on data from the ongoing phase 2 trial CA180-226 (ClinicalTrials.gov Identification: NCT00777036). The study enrolled pediatric patients who were newly diagnosed with CP-CML, or patients with CP-CML resistant or intolerant to imatinib.
Study measures included cumulative complete cytogenetic response rate in newly diagnosed patients, cumulative major cytogenetic response rate among imatinib-resistant or -intolerant patients, time to and duration of response, major molecular response, overall survival, progression-free survival, and safety.
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Frequently observed adverse events among patients treated with dasatinib include pleural effusion, fatigue, dyspnea, cough, diarrhea, appetite disturbance, lower gastrointestinal hemorrhage, myelosuppression, and fluid retention.
The priority review action date is November 9, 2017.
- U.S. Food and Drug Administration accepts for priority review Bristol-Myers Squibb's application for Sprycel (dasatinib) in children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia [news release]. Princeton, NJ: Bristol-Myers Squibb; July 10, 2017. https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-accepts-priority-review-bristo. Accessed July 10, 2017.