India is making significant strides in revolutionizing cancer treatment by developing affordable CAR-T cell therapy, a cutting-edge treatment for certain blood cancers. This initiative aims to drastically reduce the cost of the therapy, which currently ranges between ₹3-4 crore per patient in countries like the United States, to an estimated ₹25-35 lakh in India.
Under the National Biopharma Mission (NBM), spearheaded by the Biotechnology Industry Research Assistance Council (BIRAC), researchers at Tata Memorial Centre (TMC), Mumbai, have commenced the nation’s first clinical trial of CAR-T cell therapy for children. The trial focuses on relapsed/refractory B-cell Acute Lymphoblastic Leukemia (B-cell ALL), a type of blood cancer that does not respond to standard treatments.
This milestone marks the use of domestically developed CD-19-targeted CAR-T cells, manufactured at the Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), a facility within TMC. The cost-effective production process is a game-changer in making this advanced therapy accessible to a broader population.
According to Dr. Raj K Shirumalla, Mission Director of the National Biopharma Mission, “BIRAC’s support through NBM has been pivotal in bringing indigenously developed CAR-T therapy to India, significantly reducing costs and advancing clinical research to improve patient outcomes.”
The Phase II clinical trial not only aims to enhance understanding of CAR-T therapy but also holds promise in reducing symptoms, minimizing hospitalizations, and extending remission periods, offering new hope to patients who have exhausted conventional treatment options.
A major cost component of CAR-T therapy lies in the manufacturing of lentivirus, which is essential for modifying a patient’s immune cells. Lentivirus production accounts for nearly 50% of the therapy’s cost, posing a significant affordability challenge. To address this, NBM is supporting Ahmedabad-based Intas Pharmaceuticals in developing a cost-effective lentivirus production process, which could further reduce therapy costs.
As reported by indiatoday, this facility will also support pharmaceutical companies, startups, and academic institutions by providing lentivirus systems, tackling the current supply limitations in India.
In addition, BIRAC has facilitated the establishment of a GMP-compliant manufacturing unit for CAR-T cells, capable of producing treatments for not just blood cancers but also solid tumors and other non-cancerous conditions.
Dr.Shirumalla emphasized that this initiative has also contributed to building a skilled workforce in cell and gene therapy, creating a strong foundation for advancing this field in India.
By combining indigenous research, affordable manufacturing processes, and local expertise, India is taking a groundbreaking step toward making advanced cancer therapies accessible and affordable for its population.