The FDA has granted accelerated approval for tisagenlecleucel (Kymriah, Novartis) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Tisagenlecleucel is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings.
The approval is based on data from the Phase II ELARA trial, a single-arm, open-label trial, in which 90 patients were evaluated for
JUNE 3, 2022