The European Commission ( EC ) has approved Kymriah ( Tisagenlecleucel ), a CAR-T cell therapy, for the treatment of adult patients with relapsed or refractory ( r/r ) follicular lymphoma ( FL ) after two or more lines of systemic therapy.
The approval follows a positive opinion by the Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ).
This approval marks the third indication for Kymriah and makes it the first CAR-T cell therapy approved in the EU for these patients, which include those with r/r follicular lymphoma grade 1, 2 and 3A1.
The approval is based on the global phase II ELARA trial showing 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 demonstrated with an estimated 87% of patients who achieved a complete response still in response at or more than 9 months after initial response.
In the trial, 94 infused patients were evaluated for efficacy with a median follow-up of approximately 21 months.
Among 97 patients evaluable for safety, the safety profile of Kymriah was remarkable.
Cytokine release syndrome ( CRS ) was reported in 50% of patients after Kymriah infusion, and no grade 3 or 4 events were reported, as defined by the Lee scale.
Neurological adverse reactions occurred in 9% of patients ( 1% were grade 3 or 4 ) within eight weeks after Kymriah infusion.
Severe infections ( grade 3 or 4 ) occurred in 16% of patients.
In addition to r/r follicular lymphoma, Kymriah is approved for the treatment of pediatric and young adult patients up to and including 25 years of age with B cell acute lymphoblastic leukemia ( ALL ) that is refractory, in relapse post-transplant or in second or later relapse, and adult patients with r/r diffuse large B cell lymphoma ( DLBCL ) after two or more lines of systemic therapy. ( Xagena )
Source: Novartis, 2022