FDA Oks Novartis Kymriah CAR-T Cell Therapy For Relapsed Or Refractory Follicular Lymphoma

(RTTNews) - Novartis said that the US Food and Drug Administration granted accelerated approval for Kymriah or tisagenlecleucel for the treatment of adult patients with relapsed or refractory or r/r follicular lymphoma or FL after two or more lines of systemic therapy.

Under the Accelerated Approval Program, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings.

The approval was based on data from the Phase II ELARA trial, a single-arm, open-label trial, in which 90 patients were evaluated for efficacy with a median follow-up of approximately 17 months. Eighty-six percent of patients treated with Kymriah achieved a response including 68% who experienced a complete response.

Prolonged durable response to treatment was demonstrated with an estimated 85% of patients who achieved a complete response still in response 12 months after initial response.

In early May 2022, the European Commission approved Kymriah for the treatment of adult patients with r/r FL after two or more lines of systemic therapy, the third indication for which Kymriah is available to patients in the European Union.