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The European Medicines Agency recommended Novartis’ Kymriah (tisagenlecleucel) and Kite’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cell therapies, for approval in the European Union.
On June 29, 2018, the European Medicines Agency (EMA) recommended Novartis’ Kymriah (tisagenlecleucel) and Kite Pharma’s Yescarta (axicabtagene ciloleucel), chimeric antigen receptor (CAR) T-cells therapies for blood cancer, for approval in the European Union (EU).
Kymriah and Yescarta are the first CAR T-cell treatments to be recommended by the agency. In August 2017, Kymriah became the first CAR-T therapy approved by FDA in the United States, with Yescarta becoming the second in October 2017.
Both drugs are also the first treatments supported through EMA’s Priority Medicines (PRIME) scheme to receive positive opinions from the Committee for Medicinal Products for Human Use (CHMP). The scheme provides early and enhanced scientific and regulatory support to treatments that have the potential to significantly address patients’ unmet medical needs.
Kymriah was granted eligibility to PRIME in June 2016 for the treatment of acute lymphoblastic leukaemia (ALL). Yescarta was granted eligibility to PRIME in May 2016 for the treatment of diffuse large B-cell lymphoma (DLBCL). Kymriah is indicated for the treatment of children and young adult patients up to 25 years old with B-cell ALL that is refractory or in second or later relapse, and in adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. Yescarta is indicated for the treatment of adult patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.
“CAR-T cells transform the fight against serious and often fatal diseases in the EU,” said Dr Martina Schüssler-Lenz, chair of the Committee for Advanced Therapies (CAT), in an agency press release. “Kymriah and Yescarta offer an innovative approach where patients’ cells are reprogrammed and reinjected to attack the cancer.”
EMA states that because Kymriah and Yescarta are advanced-therapy medicinal products, they were evaluated by CHMP and CAT, the agency’s committee for cell-, gene- or tissue-based treatments. The CAT adopts an advisory opinion, which is taken into account by the CHMP when giving its authorization recommendation of an evaluated product.
“Innovative treatments such as CAR-T cells have potential to change the outlook for patients with cancer, but they also come with new scientific and regulatory challenges,” commented Dr. Tomas Salmonson, chair of the CHMP, in the release. “From the beginning, we have worked to establish a robust system of data collection for the post-authorization phase that would suit the specificities of these two medicines. We have used a wide range of tools-scientific advice, a specific workshop on patient registries for CAR-T cells, PRIME, to name just a few-to enable us to define the methods to tightly monitor the benefit-risk profile of these medicines and manage their risks once they are on the market, so that patients can benefit from these innovative treatments.”