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FDA Approves Dasatinib for CML in Patients Resistant, Intolerant to Prior Therapies

NEW YORK -- May 26, 2009 -- The US Food and Drug Administration (FDA) has approved dasatinib (Sprycel) for the treatment of adults in all phases of chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate.

The approval was based in part on results from a phase 3 randomised, open-label dose-optimisation study that enrolled 670 patients with chronic phase CML with resistance or intolerance to imatinib mesylate.

The primary endpoint of the study was major cytogenetic response (MCyR; 0%-35% Ph+ metaphases, which combines both complete and partial responses), in imatinib mesylate-resistant patients.

The data included a minimum of 2 years of follow-up after the start of treatment with dasatinib 100 mg once daily.

Of the 167 patients who received dasatinib, 80% had progression-free survival (95% confidence interval [CI]: 73%-87%) estimated rate at 2 years, based on Kaplan-Meier estimates and 91% overall survival (95% CI: 86%-96%) estimated rate at 2 years, based on Kaplan-Meier estimates.

In addition, 63% of patients achieved MCyR (95% CI: 56%-71%; median duration of treatment was 22 months) and 93% of patients who achieved MCyR maintained that response for 18 months (95% CI: 88%-98%), based on Kaplan-Meier estimates.

Safety data in the labelling encompasses results from 7 clinical trials and more than 2,100 patients with CML or Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The most frequently reported serious adverse reactions with dasatinib included pleural effusion (11%), gastrointestinal bleeding (4%), febrile neutropenia (4%), dyspnoea (3%), pneumonia (3%), pyrexia (3%), diarrhoea (3%), infection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%), and central nervous system (CNS) haemorrhage (1%).

The most frequently reported adverse reactions (reported in >= 20% of patients) included myelosuppression, fluid retention events, diarrhoea, headache, dyspnoea, skin rash, fatigue, nausea and haemorrhage.

SOURCE: Bristol-Myers Squibb

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