FDA Speeds Up Review of CAR-T Cell Therapy to Treat Follicular Lymphoma

The Food and Drug Administration granted a priority review of Kymriah (tisagenlecleucel) for the treatment of patients with relapsed or refractory follicular lymphoma who underwent two or more prior lines of treatment, according to Novartis, the manufacturer of the CAR-T cell therapy.

Priority reviews allow the FDA to expedite the review and approval of a treatment regimen after clinical studies show that it is a promising option. In this case, the agency based its decision on findings from the phase 2 ELARA trial, which achieved its goal of robust responses in heavily pretreated patients.

“This is an important milestone in our mission to bring Kymriah to adult patients with relapsed or refractory follicular lymphoma. Receiving … priority review from the FDA underscores the unmet need and urgency for these patients,” said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis, in a statement.

ELARA is a large clinical trial being conducted in 30 sites across 12 countries. The primary endpoint – or main goal – of the study is complete response rate (when there is no detectable cancer after treatment) in pretreated patients with relapsed/refractory follicular lymphoma. Findings presented at the ASCO 2021 Annual Meeting showed that 66% of patients on Kymriah achieved a complete response, and 86% responded to treatment in some capacity.

Secondary goals were overall response rate (percentage of patients whose cancer shrunk as a result of treatment); duration of response; progression-free survival (the time patients survived without their disease getting worse); overall survival and safety.

Kymriah proved to be extremely safe, with no patients experiencing severe (grade 3 or higher) cytokine release syndrome within eight weeks after being infused with the drug. Cytokine release syndrome is one of the most common side effects of CAR-T cell therapy and can be very dangerous if not detected and treated quickly.

“With Kymriah demonstrating impressive results in the ELARA trial, we are hopeful that we can offer a unique and potentially definitive treatment that minimizes the burden,” Legos said.

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