EMA Recommends a New Formulation and Extension of Indications for Dasatinib

It concerns treatment of paediatric patients with Ph+ CML in chronic phase

On 26 April 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product dasatinib (Sprycel). 

The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG. 

The CHMP adopted an extension to the existing indication

Sprycel is indicated for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib. 

In addition, the CHMP recommended approval of a new formulation, a powder for oral suspension, for use in paediatric patients. 

For information, the full indications for Sprycel will be as follows.

Sprycel is indicated for the treatment of adult patients with:

  • newly diagnosed Ph+ CML-CP 
  • chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate 
  • Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy

Sprycel is indicated for the treatment of paediatric patients with: 

  • newly diagnosed Ph+ CML-CP or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.