FDA approves Novartis Kymriah CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma

• 68% of patients receiving Kymriah in the ELARA trial experienced complete response, with an 86% overall response rate, along with a remarkable safety profile¹
  

• Sustained clinical benefit from Kymriah treatment demonstrated – of patients who achieved a complete response, 85% were still in response at 12 months¹

• Kymriah can be administered in the outpatient setting, offering increased flexibility and potentially reducing the burden of therapy for patients and their care teams^1,2

• Kymriah is now FDA approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings¹

Basel, May 28, 2022 — Novartis today announced the US Food and Drug Administration (FDA) 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. 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 settings¹.


"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.”

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 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 response¹.

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 response¹. Kymriah was shown to be effective in high-risk patients including those who were heavily pretreated or had refractory disease, POD24, bulky disease or those with high Follicular Lymphoma International Prognostic Index (FLIPI) scores¹.