Novartis recently submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for what it calls a novel immunocellular therapy and one-time treatment that utilizes a patient’s own T cells to fight cancer.
The application was submitted for the company's CTL019 (tisagenlecleucel) to treat children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia and adult patients with relapsed or refactory diffuse large B-cell lymphoma, according to a press release.
"Since the historic FDA approval of Kymriah, formerly CTL019, we have launched, manufactured and supplied this highly individualized immunocelluar therapy in a commercial setting and the submission to the EMA is a major step toward our goal of delivering it to more critically ill cancer patients around the world," Vas Narasimhan, Novartis' global head of drug development and chief medical officer, said in a press release.
Dr. Gilles Salles, head of Hematology Department at Hospices Civils de Lyon in Lyon, France, said this treatment could help meet the needs of patients who have relapsed.
"For patients in the EU living with these aggressive forms of blood cancer, we have very limited options to improve their chances of sustained remission after their disease has relapsed or become refractory to initial treatment," Salles said in the release. "The data for tisagenlecleucel has provided an optimistic look at the potential to achieve durable responses in two distinct and difficult-to-treat patient populations, helping to address a dire unmet need for patients."