India's First CAR-T Cell Therapy, NexCAR19, Receives Approval

• 14 Oct 2023

ImmunoACT, backed by IIT-B and Laurus Labs, has recently received approval from the Central Drugs Standard Control Organization (CDSCO) for India's maiden CAR-T cell therapy, NexCAR19 (Actalycabtagene autoleucel), for treating relapsed/refractory (r/r) B-cell lymphomas and leukemia.

Key Points

• Indigenous Development: NexCAR19 is an indigenous product, representing a significant leap in advanced cell-and-gene therapies. It is a collaborative effort spanning a decade involving IIT-Bombay and Tata Memorial Centre (TMC).
• Accessible and Affordable Treatment; NexCAR19's approval opens the door for patients in India and resource-constrained countries to access this life-saving therapy at an affordable cost.
• It marks a significant technical achievement, positioning India among the elite nations offering CAR-T therapy.
• ImmunoACT's Origin: ImmunoACT, incubated at IIT Bombay under SINE (Society for Innovation and Entrepreneurship), was established in 2018 with the aim of translating academic research into commercially viable products.
• Wider Availability: ImmunoACT intends to make NexCAR19 therapy available to partner hospitals promptly, ensuring wider accessibility and affordability of CAR-T therapy in India.