SPRYCEL(R) (dasatinib) Receives CHMP Positive Opinion for the Treatment of Adult Patients With Newly Diagnosed Philadelphia

Publicado el 22 octubre 2010 por Fat
Bristol-Myers Squibb today announced that SPRYCEL(r) (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)[*] 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."
-DASISION Study Results
In the ongoing DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) study, results of which were published in the NEJM in June 2010,[1] 77% of patients in the dasatinib arm vs. 66% of patients in the imatinib arm achieved confirmed CCyR (two consecutive assessments of CCyR) within 12 months (p=0.007). Additionally, 83% of dasatinib patients vs. 72% of imatinib patients achieved CCyR by one year (p=0.001). The time to CCyR was shorter for dasatinib patients than imatinib patients (hazard ratio = 1.5, p<0.0001), with more than half of dasatinib patients (54%) achieving CCyR within three months. Dasatinib patients were also twice as likely as imatinib patients to achieve a major molecular response[**] (MMR), a more sensitive method of assessment of treatment response,[2,3] during the course of the study (hazard ratio = 2.0, p<0.0001).
Commonly reported adverse events[1] (of all grades) with dasatinib and imatinib respectively included superficial oedema (9% and 36%), pleural effusions (10% and 0%), nausea (8% and 20%), rash (11% and 17%) and muscle inflammation (4% and 17%).

Volver a la Portada de Logo Paperblog