EU CHMP recommends approval of Kymriah for relapsed or refractory follicular lymphoma.- Novartis

The CHMP positive opinion is based on results from the global Phase II ELARA trial, in which 94 infused patients were evaluated for efficacy with a median follow-up of approximately 17 months. Among patients treated with Kymriah, 86% had a response, including 69% who experienced a complete response (CR). Prolonged durable response to treatment was demonstrated with an estimated 87% of patients who experienced a CR still in response nine months after initial response.

In the ELARA trial, for the 97 patients evaluable for safety, the safety profile of Kymriah was remarkable. Within eight weeks of infusion, 49% of patients experienced cytokine release syndrome (CRS) and there were no reported cases of high-grade (grade 3 or higher) CRS, as defined by the Lee scale. Grade 3 or 4 neurological events occurred in 3% of patients within eight weeks of infusion.