FDA nod for Novartis' CAR-T cell therapy Kymriah for adult patients with r/r FL

The US Food and Drug Administration has granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy, said Swiss pharma giant Novartis (NOVN: VX), and follows shortly after the European Commission authorized the CAR-T cell therapy for the same indication.

In accordance with 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, Novartis noted.

"We are proud of today's FDA approval of a third indication for Kymriah. We hope this treatment option that has the potential for long-lasting results may help break the unrelenting cycle of treatment for patients with follicular lymphoma,” said Victor Bulto, president, Novartis Innovative Medicines US. “We are on a mission to build on our pioneering work in cell therapy and continue to innovate for patient impact.”