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FDA approves lower starting dose for dasatinib for CML

FDA approves lower starting dose for dasatinib for CML

ROCKVILLE, Maryland—FDA has approved new labeling for Bristol-Myers Squibb's Sprycel (dasatinib) to include a lower recommended starting dose of 100 mg once daily, and safety and efficacy data in a greater number of patients with chronic-phase chronic myeloid leukemia resistant or intolerant to prior therapy including imatinib (Gleevec). The product labeling now also includes data from the first randomized trial of Sprycel and imatinib.

Sprycel, which was granted accelerated approval in 2006, is indicated for the treatment of adults with chronic-, accelerated-, or myeloid or lymphoid blast-phase CML with resistance or intolerance to prior therapy including imatinib. FDA also granted regular approval of Sprycel for the treatment of adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy.

The effectiveness of Sprycel is based on hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Resistance to imatinib is often due to mutations of Bcr-Abl, Bcr-Abl overexpression, or activation of new pathways. Sprycel is the first approved oral multiple tyrosine kinase inhibitor that, at nanomolar concentrations, inhibits Bcr-Abl, SRC family, c-KIT, EPHA2, and PDGFRb kinases.

Fewer side effects

"The new, lower once-daily dose reduces the incidence of some side effects while preserving the efficacy of Sprycel for patients with chronic-phase CML no longer responding to currently approved therapies," Hagop Kantarjian, MD, chairman and professor, Leukemia Department, M.D. Anderson Cancer Center, told ONI. "Importantly, the new clinical data now included in the labeling provides further evidence to support the use of Sprycel to treat patients with chronic-phase CML, if their disease is no longer responding to currently available treatment including Gleevec."

The updated labeling was granted priority review and was approved in 6 months based primarily on two studies that enrolled chronic-phase CML patients with resistance or intolerance to imatinib.

Dose-optimization study


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