Kymriah’s approval follows a positive CHMP opinion and applies to all 27 EU member states
The European Commission (EC) has approved Kymriah (tisagenlecleucel), a CAR-T cell therapy for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in March and applies to the 27 EU member states plus Iceland, Norway and Liechtenstein. This approval makes Kymriah the first CAR-T cell therapy of its kind approved in the EU.
The verdict is based on the global Phase 2 ELARA trial, which demonstrated that 86% of patients treated with Kymriah had a response, including 69% who had a complete response (CR). A prolonged durable response to treatment was observed in 87% of patients who achieved a CR response nine months after the initial response.
“When follicular lymphoma does not respond to treatment or comes back, it is usually more aggressive and difficult to treat; patients often end up going through multiple lines of therapy with diminishing benefit,” said Catherine Thieblemont, head of the hematology-oncology unit at St. Louis Hospital.
“Kymriah’s approval in Europe brings patients one step closer to a potentially definitive treatment, giving us hope for improved outcomes,” she added.
“With this approval, we are thrilled to be able to bring this transformative therapy to more people around the world with this advanced blood cancer,” added Marie-France Tschudin, President, Global Innovative Medicines and Chief Commercial Officer, Novartis.
“With lasting answers and a safety profile that allows for flexible administration, we are striving to rewrite cancer survival and lessen the burden of this disease on patients and the healthcare system.”