Approval for Kymriah follows a positive CHMP opinion and is applicable 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.
Approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in March, and is applicable to all 27 EU member states plus Iceland, Norway and Liechtenstein. The 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 who were treated with Kymriah had a response, including 69% who had a complete response (CR). Prolonged durable response to treatment was shown in 87% of patients who achieved a CR response nine months after the initial response.
“When follicular lymphoma fails to respond to treatment or comes back, it is typically more aggressive and difficult to treat; patients often end up cycling through multiple lines of therapy with decreasing benefit,” said Catherine Thieblemont, head of the haemato-oncology unit of St-Louis Hospital.
“The approval of Kymriah in Europe brings patients closer to a potentially definitive therapy, providing us hope for improved outcomes,” she added.
“With this approval, we are pleased to be able to offer this transformative therapy to more people across the globe living with this advanced blood cancer,” added Marie-France Tschudin, president, innovative medicines international and chief commercial officer at Novartis.
“With long-lasting responses and a safety profile that allows for flexible administration, we are striving to rewrite cancer survival and alleviate the burden of this disease for patients and the healthcare system.”