Bristol-Myers Squibb’s Sprycel gets double FDA OK

Sprycel (dasatinib) is the first approved oral tyrosine kinase inhibitor predicted to bind to multiple conformations of the ABL kinase based on modeling studies. The drug's effectiveness 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.

The FDA also granted full approval of Sprycel for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) with resistance or intolerance to prior therapy.

The FDA reviewed the efficacy and safety of Sprycel based on the analysis of four phase II multi-center studies in patients with resistance or intolerance to imatinib (Gleevec) in all phases of chronic myeloid leukemia (CML) or Ph+ ALL. The studies were conducted in 33 countries.

“Sprycel builds on our company's long legacy of providing innovative oncology medicines to patients around the world,” said Peter Dolan, CEO of Bristol-Myers Squibb. “Discovered and developed in our own research facilities, Sprycel is a key part of our robust pipeline of anticancer compounds.”