The EMA has recommended granting European Commission (EC) approval to Novartis’ CAR T-cell therapy, Kymriah® (tisagenlecleucel), to treat adult relapsed or refractory (r/r) follicular lymphoma (FL) patients. In April 2020, the US Food and Drug Administration granted regenerative medicine advanced therapy (RMAT) designation to Kymriah® for treating r/r FL. At present, the CAR T-cell therapy is approved in the EU to treat pediatric and young adults up to and including 25 years, with r/r B cell acute lymphoblastic leukemia and adults with r/r/ diffuse large B cell lymphoma. If the EC grants approval, r/r FL would become the third indication for use of Kymriah® in the EU.

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