EMA Recommends Extension of Indications for Blinatumomab

New indication concerns monotherapy in paediatric patients with Philadelphia chromosome negative, CD19-positive B-cell precursor ALL which is refractory or in relapse

On 26 July 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 blinatumomab (Blincyto).

The marketing authorisation holder for this medicinal product is Amgen Europe B.V. 

The CHMP adopted an extension of indication as follows: 

Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative, CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

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

  • Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative, CD19-positive relapsed or refractory B-precursor ALL.
  • Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with Philadelphia chromosome negative, CD19-positive B-cell precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation.

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.