NEW YORK – Novartis on Wednesday announced that based on positive results from a planned interim analysis of the Phase II ELARA trial, it plans to file new US and EU regulatory submissions for its CAR T-cell therapy tisagenlecleucel (Kymriah) for patients with relapsed or refractory follicular lymphoma.
Novartis plans to announce the data at an upcoming medical meeting. The firm said in a statement that the treatment had met its primary endpoint of complete response rate as assessed by an independent review committee and there were no new safety signals.
The CAR T-cell therapy is already approved in the US and in over a dozen other countries as a one-time treatment for pediatric or young adult patients with relapsed or refractory acute lymphoblastic leukemia, as well as for adults with relapsed or refractory diffuse large B-cell lymphoma.
Based on preliminary findings from the ELARA trial, the US Food and Drug Administration granted tisagenlecleucel the Regenerative Medicine Advanced Therapy designation. Now, Novartis anticipates submitting a regulatory filing with the FDA in 2021, and in the EU following that.
"We are pleased that Kymriah is showing meaningful results and may provide a potentially definitive treatment option for patients with relapsed and refractory follicular lymphoma," John Tsai, Novartis' head of global drug development, said in a statement. "These results further support our efforts to reimagine medicine in this incurable malignancy and reach this underserved patient population, who are historically burdened with several years of various treatments."