Novartis has announced that the European Commission (EC) has approved its CAR-T cell therapy, Kymriah (tisagenlecleucel), for the treatment of adult patients with relapsed or refractory follicular lymphoma, an advanced blood cancer, after two or more lines of systemic therapy.
The EC’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued in March, making Kymriah the first CAR-T cell therapy of its kind approved in the EU.
The approval applies to all 27 EU member states, as well as Iceland, Norway and Liechtenstein.
The ELARA trial formed the basis of the decision as a global phase 2 study, which demonstrated that 86% of patients who were treated with Kymriah had a response, including 69% who had a complete response.
Prolonged durable response to treatment was reported in 87% of patients who achieved a complete 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 with hope for improved outcomes,” she added.
In addition to refractory follicular lymphoma, Kymriah is also approved to treat paediatric and young adults up to and including 25 years of age with B cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant, or in a second or a later relapse.
The treatment has also been approved for adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), following two or more systemic therapies.
“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.”