NEW YORK – Novartis on Wednesday said it has filed applications with both the US Food and Drug Administration and the European Medicines Agency seeking approval of its autologous CAR T-cell therapy tisagenlecleucel (Kymriah/tisa-cel) for previously treated, relapsed or refractory follicular lymphoma patients.
The firm filed a supplemental biologics licensing application and a type II variation application with the FDA and EMA, respectively, which includes results from the Phase II ELARA trial. In that study, the overall response rate was 86 percent on tisa-cel, and 66 percent of 94 evaluable follicular lymphoma patients achieved a complete response. Additionally, no patients experienced grade 3 or 4 cytokine release syndrome during the first eight weeks following tis-cel infusion.
Novartis is seeking approval for the anti-CD19 autologous cell therapy in refractory follicular lymphoma patients who have received at least two prior lines of therapy. The FDA has granted orphan drug designation and priority review to tisa-cel for this indication, and the European Commission and the Japan Ministry of Health, Labor, and Welfare have also granted the CAR T-cell therapy orphan medicinal product designation.
"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," Jeff Legos, Novartis' executive VP and global head of oncology and hematology development, said in a statement.