News & Press Releases: Breaking News

EU LRA Regulatory WatchDog Update: First Two CAR T-Cell Medicines Recommended for Approval in the EU

Wednesday, July 4, 2018  
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ISCT EU Legal and Regulatory Affairs (LRA) Update

The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU).
On 28 June 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yescarta (axicabtagene ciloleucel), intended for the treatment of diffuse large cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL) and also for the medicinal product Kymriah (tisagenlecleucel), intended for the treatment of acute lymphoblastic leukaemia (ALL) and diffuse large B‑cell lymphoma (DLBCL). As Yescarta and Kymriah are advanced therapy medicinal products, the CHMP positive opinions are based on the assessment by the Committee for Advanced Therapies.
Kymriah and Yescarta are also the first medicines supported through EMA’s PRIority MEdicines (PRIME) scheme to receive positive opinions from the Committee for Medicinal Products for Human Use (CHMP).
The opinions adopted by the CHMP are an intermediary step on Kymriah’s and Yescarta path to patient access. The CHMP opinions will now be sent to the European Commission for the adoption of decisions on EU-wide marketing authorisations. Once the marketing authorisations have been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of these medicines in the context of the national health system of that country.
For full press release, click here
View the most recent EU LRA Regulatory WatchDog Report from the June Telegraft issue. 

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