Bristol-Myers Squibb today announced that SPRYCEL (dasatinib) received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive Chronic Myelogenous Leukaemia in Chronic Phase (CML-CP).
This decision follows the presentation of results from the pivotal DASISION study in which dasatinib 100 mg once daily demonstrated a superior rate of confirmed complete cytogenetic response (CCyR)Complete cytogenetic response (CCyR) is defined as the absence of Philadelphia chromosome-positive metaphases on cytogenetic assessment of bone marrow cells. compared to imatinib by 12 months in chronic phase CML patients.
The data was presented as a late-breaking abstract at the 46th Annual Meeting of the American Society of Clinical Oncology, during the Best Abstracts section of the Presidential Symposium at the 15th Congress of the EHA and published in New England Journal of Medicine in June 2010.
The European Medicines Agency’s (EMA) CHMP adopted the positive opinion based on the 12 month results from the DASISION trial. The European Commission generally grants the Marketing Authorization within three months of a positive CHMP opinion.
Commenting on the developments BMS spokesperson Renzo Canetta, Vice-President, Oncology Global Clinical Research, said: “Bristol-Myers Squibb is committed to working together with regulatory authorities in different countries around the world to help ensure that CML patients and their physicians are provided with treatment options that can achieve optimal outcomes for their patients whether they are newly diagnosed or resistant or intolerant to previous treatment.”
Source: Bristol-Myers Squibb