FDA Gives Accelerated Approval to Novartis’ Kymriah for Follicular Lymphoma

The FDA has granted accelerated approval for Novartis’ chimeric antigen receptor (CAR)-T cell drug Kymriah (tisagenlecleucel) for the treatment of patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

The approval was supported by data from a 90-participant clinical trial in which 68 percent of patients experienced a complete response.

Under the terms of the accelerated approval, the company must conduct one or more confirmatory clinical trials to demonstrate the treatment’s benefit.

Kymriah is also approved for patients up to 25 years old who have B-cell precursor acute lymphoblastic leukemia that is refractory or in second or later relapse and for patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

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