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Leukemia treatment approved

The US FDA has granted full approval for Bristol-Myers Squibb's Sprycel for the treatment of adults in all phases of chronic myeloid leukemia

The US Food and Drug Administration (FDA) has granted full approval for Bristol-Myers Squibb's Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy, including Novartis' Gleevec (imatinib mesylate).

Sprycel, an oral tyrosine kinase inhibitor, was originally approved under the accelerated approval regulations of Subpart H for new drugs for serious or life-threatening illnesses of the Food, Drug and Cosmetic Act, based on its effectiveness on hematologic and cytogenetic response rates in CML.

The full approval was based in part on results from a Phase 3 study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The data included a minimum of two years of follow-up after the start of treatment with Sprycel 100 mg once daily. Results from the 167 patients who received Sprycel 100 mg once daily included an 80 per cent progression-free survival estimated rate at two years, and a 91 per cent overall survival estimated rate at two years, both based on Kaplan-Meier estimates.

"Sprycel helps to fulfill a need for second-line treatments for CML patients with resistance or intolerance to Gleevec. The two-year follow-up data further support the use of Sprycel as an important treatment option for this patient population," said Dr Hagop Kantarjian, chairman and professor, Leukemia Department, MD Anderson Cancer Center.

The approved label also now includes a new recommended starting dosage of Sprycel (dasatinib) 140 mg once daily for accelerated, myeloid blast and lymphoid blast phase CML resistant or intolerant to prior therapy including Gleevec and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) resistant or intolerant to prior therapy.

Safety data in the labelling encompasses results from seven clinical trials and more than 2,100 patients with CML or Ph+ ALL.

27th May 2009

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