It is a major breakthrough as the therapy is not available in India outside of clinical trials
Photo: iStock For treating relapsed-refractory B-cell lymphoma and leukemia, Mumbai-based Immunoadoptive Cell Therapy Private Limited (ImmunoACT) announced the approval of India’s first chimeric antigen receptor (CAR) T-cell therapy by the Central Drugs Standard Control Organization (CDSCO) on October 13, 2023.
Called NexCAR19, it is an indigenously developed CD19-targeted CAR-T cell therapy. CD-19 is biomarker for B lymphocytes and can be utilised as a target for leukemia immunotherapies.
ImmunoACT is an IIT Bombay-incubated company founded in 2018 and works on converting research into pharmaceutical products.
How does the treatment work? For CAR-T-cell therapy, a type of cancer immunotherapy treatment, blood is first drawn from the patient. Then, immune cells called T-cells are genetically modified in a laboratory and are injected back into the patient to enable the cells to locate and destroy cancer cells more effectively.
Investigations were led by Dr Hasmukh Jain and Dr Gaurav Narula and their teams at Tata Memorial Hospital in Mumbai. It is a major breakthrough as the therapy is not available in India outside of clinical trials.
The multi-centre Phase I and II clinical trials were conducted with 60 patients with r / r B-cell lymphomas and leukemia. The clinical data indicated a 70 per cent overall response rate.
ImmunoACT received market authorisation for our CAR-T cell therapy from the Drugs Controller General of India yesterday and henceforth, eligible patients for the treatment can register with the hospitals offering it, Rahul Purwar, chief executive of ImmunoACT, told news website The Print.
CAR T-cell therapy is generally accompanied by some side effects. One of them, according to the American Cancer Society, is cytokine release syndrome (CRS). It is when CAR T-cells multiply, they can release large amounts of chemicals called cytokines into the blood, which can ramp up the immune system.
In comparison to other CAR T-cell therapies, the safety profile of CRS and the absence of neurotoxicity indicates a significant improvement, the company vouched. Dr Jain, an associate professor at Tata Memorial Centre, said in a press release, “NexCAR19 has shown an excellent balance of efficacy and low toxicity, which is a significant advantage in clinical management (post-infusion) of the patients in our resource-constrained settings.”
Priorly, CAR-T cell therapy cost around $400,000 or over Rs 3.3 crore and patients could avail of it in the United States. With this development, the therapy will be accessible at 20 Indian government and private hospitals treating cancer across major cities at around Rs 30-35 lakh per patient, The Print reported.
"Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost. In terms of technical achievement, this is comparable to the moon shot and it puts India on the elite list of select countries that have access to CAR-T therapy,” Purwar said in a press release.
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