EMA Recommends Extension of Existing Paediatric Indications for Dasatinib

New indication concerns the treatment of newly diagnosed Ph+ ALL in combination with chemotherapy

On 13 December 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change 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 its existing paediatric indication to include the treatment of newly diagnosed Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia (ALL) in combination with chemotherapy.

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

Sprycel is indicated for the treatment of adult patients with:

  • newly diagnosed Ph+ chronic myelogenous leukaemia (CML) in the chronic phase.
  • chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate.
  • Ph+ 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 in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.
  • newly diagnosed Ph+ ALL in combination with chemotherapy.

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.