BMS’ Sprycel Cleared in EU for Newly Diagnosed Ph+ CML Therapy

Phase III study demonstrated superior efficacy over Novartis’ Gleevec.

Bristol-Myers Squibb (BMS) reported European approval for Sprycel® (dasatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The latest clearance for the drug was based on data from the open-label Dasision study, which compared oral dasatinib therapy with oral imatinib (Novartis’ Gleevec) treatment in 519 patients.

The results showed that 77% of dasatinib patients achieved the primary endpoint of confirmed CCyR by 12 months of therapy, compared with 66% of imatinib-treated patients. Median time to major molecular response was 6.3 months among 135 dasatinib responders, and 9.2 months for the cohort of 88 imatinib responders. The Dasision study is ongoing to generate data about long-term outcomes.

BMS says the latest approval in Europe marks the first for a new drug that has shown superior efficacy to imatinib in this patient population since 2001. Sprycel was first approved by the European Union and in the U.S. in 2006 for the treatment of adult patients at all stages of CML who were resistant to or intolerant to prior therapy, including treatment with imatinib. The drug is also approved in both regions for the treatment of adults with Ph+ acute lymphoblastic leukemia who are resistant to or intolerant to prior treatment. Commercialization of Sprycel in the U.S. and Japan has been partnered with Otsuka Pharmaceutical.

Sprycel made global sales of $421 million in 2009, and $407 million in the first nine months of 2010, compared with $302 million during the first nine months of 2009.