Regulatory News

New treatments of lymphoma and CLL normally need to be approved by the European Medicines Agency (EMA) before they can be funded by the national health systems and be accessible to patients in the European Union (EU) and in the European Economic Area (EEA) countries, i.e. Iceland, Liechtenstein and Norway. In other European countries, the marketing authorisation delivered by the European Commission after approval of the drug by the EMA shall also have an influence on the decision of the national regulation authorities and thus on access to treatment.

This page is therefore dedicated to updates on approval of lymphoma and CLL drugs by the EMA and also includes news that may be relevant to the process of medicines’ approval and access in Europe.

22 January 2018
European Commission approves ADCETRIS® for CD30-positive cutaneous T-cell lymphoma after one prior systemic therapy, an important milestone for the CTCL community in Europe. 

17 January 2018
The European Medicines Agency (EMA) has granted an accelerated assessment to a marketing authorization application for Kymriah (tisagenlecleucel), for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This CAR T-cell therapy, previously called CTL019, will be approved for patients who have relapsed after a stem cell transplant or are not eligible for one.

24 July 2017
The European Commission announced it is preparing three opinions on pricing models for innovative medicines, access to healthcare and performance of primary care. These opinions will be ready in the second semester of 2017 and will feed into the further policy work of the Commission.

20 July 2017 
The EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending to extend the terms of the marketing authorisation for Gazyvaro. The new indication regards the treatment of patients with previously untreated advanced follicular lymphoma. 

4 July 2017
On 4 July, the EMA and the European Network for Health Technology Assessment (EUnetHTA) have launched a new joint platform to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. Patient representatives will be involved in parallel consultations on a routine basis so that their views and experiences can be incorporated into the discussions.

19 June 2017
The European Commission (EC) has approved Rixathon – a biosimilar of rituximab marketed by Sandoz GmbH – for use in all indications of the reference medicine. Rixathon is the second biosimilar of rituximab to receive a marketing authorisation in Europe after Truxima (Celltrion Healthcare) was approved by the EC in February.




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