On August 30, 2017, Novartis made history when the company received approval from the U.S. Food & Drug Administration for tisagenlecleucel, a gene therapy for treatment of childhood leukemia. Seven weeks later, Kite Pharma followed, receiving FDA approval for axicabtagene ciloleucel, for non-Hodgkin lymphoma. It took three decades of research and clinical testing for the FDA to give its first-ever approvals for gene-therapy products.
Both tisagenlecleucel and axicabtagene ciloleucel are dramatically different from any drugs previously approved by FDA. Most notably, they are patient-specific drugs: T-cells from the leukemia patients’ immune systems are harvested and genetically reprogrammed to express a chimeric antigen receptor (CAR) protein. The modified CAR T-cells are reinfused into patients to hunt their cancerous prey.
Read more
▼
Radically different biologic drugs like tisagenlecleucel and axicabtagene ciloleucel require a radically different style of manufacture. This webinar will look at challenges facing researchers and product development teams, as this technology becomes more widely adopted as a treatment.
Brought to you by:
