On 24 March 2022, 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 tisagenlecleucel (Kymriah).
The marketing authorisation holder for this medicinal product is Novartis Europharm Limited.
The CHMP adopted a new indication for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The full indications for Kymriah will therefore be as follows (new indication in bold):
Kymriah is indicated for the treatment of:
- Paediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukaemia that is refractory, in relapse post-transplant or in second or later relapse.
- Adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
- Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic 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.