Novartis announced that the US FDA approved Kymriah (tisagenlecleucel) for patients with relapsed or refractory (r/r) follicular lymphoma (FL) who were previously treated with two or more systemic therapies. As per the accelerated approval program, complete approval is subjected to efficacy determination by confirmatory trials.
The approval was based on the Phase II ELARA trial; efficacy was evaluated in 90 patients after a median follow-up of 17 months. 68% of patients achieved a complete response, and 86% of patients achieved a response.
Among the patients who achieved complete response, after 12 months of the initial response, 85% of patients demonstrated prolonged durable response. Kymriah was found to be effective against highly pretreated patients or refractory to disease, bulky disease, or with high Follicular Lymphoma International Prognostic Index (FLIPI) scores.
Novartis announced that Kymriah has a good safety profile; 53% of patients reported any-grade cytokine release syndrome (CRS), and no high-grade CRS was reported.
Patients with follicular lymphoma may experience four to thirteen lines of treatment. Though there are several systemic therapies available, the treatment effect decreases significantly in the later lines of treatment.
In May 2022, Kymriah received approval from European Commission for adult patients with r/r FL who had two or more systemic therapies. Kymriah was previously approved for ALL and DLBCL in Europe and the US.