COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION?for SPRYCEL International Nonproprietary Name (INN): dasatinib
On 21 September 2006 the EU EMEA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,recommending to grant a marketing authorisation for the medicinal product Sprycel, 20 mg, 50 mg and 70 mg, film-coated tablets intended for treatment of adult patients with chronic myeloid leukaemia (CML) or Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) with resistance or intolerance to prior therapy. Sprycel was designated as an orphan medicinal product on 23 December 2005. The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG. The active substance of Sprycel is dasatinib, which inhibits the activity of the BCR-ABL kinase and SRC family kinases along with a number of other selected oncogenic kinases including c-KIT, ephrin (EPH) receptor kinases, and PDGF? receptor. The benefits with Sprycel are its haematological and cytogenetic response rates in patients who had failed or been unable to tolerate prior imatinib therapy. The most common non-haematological side effects are gastrointestinal (diarrhea, nausea, and vomiting), fluid retention events (peripheral edema and pleural effusion), headache, and fatigue. The approved indication is: “Sprycel is indicated for the treatment of adults with chronic, accelerated or blast phase chronic myeloid leukaemia (CML) with resistance or intolerance to prior therapy including imatinib mesilate. Sprycel is also indicated for the treatment of adults with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy”. Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Detailed conditions for the use of this product will be described in the Summary of Product Characteristics (SPC) which will be published in the European Public Assessment Report (EPAR) and will be available in all official European Union languages after the marketing authorisation has been granted by the European Commission. The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favourable benefit to risk balance for Sprycel and therefore recommends the granting of the marketing authorisation.