Immunoadoptive Cell Therapy Private Limited (ImmunoACT), based in Mumbai, has received market authorization for India’s first chimeric antigen receptor (CAR) T-cell therapy, known as NexCAR19. This indigenous therapy, targeting CD19, a biomarker for B lymphocytes, has been approved by the Central Drugs Standard Control Organization (CDSCO) on October 13, 2023. This milestone marks a significant advancement in the treatment of relapsed-refractory B-cell lymphoma and leukemia, making CAR-T cell therapy more accessible to patients within India.
Indigenous Advancement
ImmunoACT, founded in 2018 and incubated by IIT Bombay, specializes in converting research into pharmaceutical products. NexCAR19 is a breakthrough product in this endeavor, signaling India’s growing capacity for developing innovative medical solutions.
How CAR-T Cell Therapy Works
CAR-T-cell therapy, a form of cancer immunotherapy, involves a series of steps. First, the patient’s blood is drawn, and immune cells called T-cells are genetically modified in a laboratory. These modified T-cells are then reintroduced into the patient’s body, enhancing their ability to locate and destroy cancer cells more effectively.
Clinical Trials and Success
The development of NexCAR19 was the result of extensive research led by Dr. Hasmukh Jain and Dr. Gaurav Narula and their teams at Tata Memorial Hospital in Mumbai. Notably, this therapy was previously available only through clinical trials in India. Multi-center Phase I and II clinical trials involving 60 patients with relapsed/refractory B-cell lymphomas and leukemia revealed an impressive 70% overall response rate.
Safety Profile and Accessibility
One common side effect associated with CAR-T cell therapy is cytokine release syndrome (CRS). It occurs when the modified T-cells release a large amount of cytokines into the bloodstream, activating the immune system. ImmunoACT has emphasized that compared to other CAR T-cell therapies, NexCAR19 boasts a favorable safety profile with an absence of neurotoxicity.
Previously, CAR-T cell therapy came at a high cost, approximately $400,000 or over Rs 3.3 crore, and patients often had to seek treatment in the United States. With this breakthrough, the therapy will become accessible at around Rs 30-35 lakh per patient in 20 Indian government and private hospitals in major cities, significantly reducing the financial burden on patients.
Affordable Life-Saving Treatment
The market authorization of NexCAR19 represents a monumental stride in cancer treatment in India. This innovative therapy promises to provide more accessible and effective treatment options for patients, potentially transforming the landscape of cancer care in the country.
