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EMA Recommends Extension of Indications for Blinatumomab

New indication concerns the treatment of paediatric patients with high-risk first relapsed Philadelphia chromosome negative CD19-positive B-precursor ALL
09 Jun 2021
Cancer Immunology and Immunotherapy;  Cancer in Special Situations / Population;  Haematologic malignancies

On 20 May 2021, 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 a new indication as follows:

Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19-positive B-precursor acute lymphoblastic leukaemia (ALL) as part of the consolidation therapy.

For information, the full indications for Blincyto will be as follows (new indication in bold):

Blincyto is indicated as monotherapy for the treatment of adults with CD19-positive relapsed or refractory B-precursor ALL. Patients with Philadelphia chromosome positive B-precursor ALL should have failed treatment with at least 2 tyrosine kinase inhibitors and have no alternative treatment options.

Blincyto is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19-positive B-precursor ALL in first or second complete remission with minimal residual disease greater than or equal to 0.1%.

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

Blincyto is indicated as monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19-positive B-precursor ALL as part of the consolidation therapy.

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.

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