The committee voted in favor of accelerated approval of the drug for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy, including Novartis' Gleevec.
The committee also recommended full approval of dasatinib for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to Gleevac.
While the FDA is not bound by the committee's recommendations, they generally follow the advice of the panel.
When Bristol-Myers Squibb submitted its new drug application (NDA) for dasatinib, the FDA granted a priority review – a status reserved for products that address unmet medical needs. Based on the priority review, the FDA's action date for the NDA is June 28, 2006.
“Bristol-Myers Squibb is dedicated to conducting research and to developing therapies designed to aid in the fight against serious diseases with unmet medical needs, such as leukemias and other malignancies,” said Elliott Sigal, chief scientific officer, and president of the Pharmaceutical Research Institute at Bristol-Myers Squibb. “We are committed to working with the FDA to support the potential approval of dasatinib.”