FDA Approves Labeling Update to Include New Sprycel Data
The FDA approved a product labeling update for dasatinib (Sprycel) for Ph+, chronic myeloid leukemia.
Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. have announced that the U.S. Food and Drug Administration had approved a product labeling update for dasatinib (Sprycel) to include 5-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase and 7-year data in patients with Ph+ CML in chronic phase who are refractory to prior therapy, including imatinib.
“The 5- and 7-year data now included in the Sprycel U.S. label offer valuable insight into its long-term efficacy and safety profile in both first- and second-line patients,” said Neil Shah, MD, PhD, associate professor, Division of Hematology/Oncology, University of California, San Francisco.
“CML requires ongoing treatment and assessment of treatment milestones in order to manage the disease properly. Given the chronic nature of CML, these long-term data are particularly important for patient care.”
In addition to approving dasatinib for newly diagnosed patients with Ph+ CML in chronic phase, the label was updated to include new warnings and precautions on myelosuppression, fluid retention, and severe dermatologic reactions.
The update is based on results from the open-label, randomized, international, phase 3 DASISION Study, which evaluated dasatinib 100 mg once daily vs imatinib 400 mg once daily in 519 patients with newly diagnosed chronic phase Ph+ CML, and the open-label, randomized, dose optimization study, which assessed the safety and efficacy of dasatinib in 670 patients with chronic phase Ph+ CML with resistance or intolerance to imatinib.
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“We are proud to have generated this important 5- and 7-year data in the first- and second-line treatment of CP Ph+ CML, as the findings further support the overall efficacy and safety profile of Sprycel over the long-term,” said Laura Bessen, MD, Vice President, head of U.S. Medical, Bristol-Myers Squibb.
- FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Five-Year First-Line and Seven-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase [news release]. Princeton, NJ: Bristol-Myers Squibb Company; August 13, 2015. http://news.bms.com/press-release/fda-approves-us-product-labeling-update-sprycel-dasatinib-include-five-year-first-line. Accessed August 13, 2015.