Novartis' First-in-Class CAR-T Therapy CTL019 Granted Second Clinical Trial Approval in China for Long-Term Follow-Up Study
Novartis
Drug Development and Manufacturing
According to the latest public announcement made today by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration, the clinical trial application (acceptance number: JXSL1900121) for the CAR-T cell therapy CTL019 submitted by Novartis has received implicit approval for clinical trials. The indication is:Long-term Follow-up of Patients Exposed to Lentiviral-based CAR-T Cell TherapyNotably,CTL019 is a breakthrough CAR-T novel drug under Novartis and the first CAR-T therapy approved by the U.S. FDA。
Image source: CDE official website
CTL019 (tisagenlecleucel) is a genetically engineered autologous T-cell immunotherapy. The treatment process begins with the extraction of T cells from the patient, followed by genetic modification at a manufacturing center. These T cells are engineered to express a novel chimeric antigen receptor (CAR), enabling them to directly target and destroy leukemia cells bearing the CD19 antigen. Once modified, the T cells are infused back into the patient for therapeutic purposes.
As the world’s first CAR-T therapy, CTL019 can be said to have ushered in a new chapter in cancer immunotherapy. It once received from the U.S. FDABreakthrough Therapy Designation, Priority Review Status, and Fast Track Designation。
CTL019 originated at the University of Pennsylvania. In 2012, Novartis entered into a global collaboration agreement with the University of Pennsylvania to jointly research, develop, and commercialize multiple CAR-T therapies, including CTL019. In the following years, Novartis successively released clinical data on this therapy, demonstrating its efficacy and safety in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). Years of investment and effort ultimately bore fruit. In July 2017, the FDA’s Oncologic Drugs Advisory Committee (ODAC) convened an evaluation meeting for Novartis’ CAR-T therapy CTL019,Unanimously recommended for approval with a 10-0 vote.。