Novartis Gets Expanded OK for Kymriah

FDA has granted Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Kymriah was the first CAR-T cell therapy to receive regulatory approval 8/2017, for treating patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse. The immunocellular therapy uses a patient’s own T cells to fight cancer.

Approval is based on data from the company’s Phase 2 ELARA trial, a single-arm, open-label trial involving 90 patients who were evaluated for efficacy with a median follow-up of about 17 months, according to the company. “Eighty-six percent of patients treated with Kymriah achieved a response including 68% who experienced a complete response,” the company says.