Recently, the Central Drugs Standard Control Organisation (CDSCO) granted market authorisation for NexCAR19, marking a significant milestone as India’s first indigenously-developed Chimeric Antigen Receptor T cell (CAR-T cell) Therapy. India’s position in the global health community takes a leap forward, becoming one of the first developing countries to have made such a stride in CAR-T and gene therapy platform.
A Close Look at NexCAR19
NexCar19 is a breakthrough CAR-T and gene therapy that was developed indigenously by ImmunoACT, a company nurtured within the incubation environment of IIT Bombay. Designed with precision, it targets cancer cells bearing the CD19 protein, which is identifiable like a flag on these cells. This unique identification enables CAR-T cells to recognise these cancer cells, latch onto them and initiate the elimination process.
The development of indigenous CAR-T therapies is still a challenge faced by some developed nations. The current scenario often involves importing these therapies from bigger economies like the United States or Europe.
Patient Eligibility
NexCAR19 brings hope to patients with B-cell lymphomas who have shown resistance to conventional treatments like chemotherapy and also those whose cancer has relapsed or resurfaced. The approval of this therapy currently extends to patients aged 15 years and above.
Procedure Followed
Entering the treatment phase, the process begins with the patient donating blood at a transfusion center. Having collected the blood, the T-cells undergo genetic modification and are reintroduced into the patient’s system over a span of 7-10 days.
Efficacy of NexCAR19
NexCAR19 therapy offers a robust solution with significantly reduced drug-related toxicities. It inflicts minimal damage to neurons and the central nervous system, minimizing the risk of neurotoxicity. Neurotoxicity, a potential threat to life, can occur if the CAR-T cells identifying the CD19 protein enters the brain.
The therapy’s design also ensures it results in Minimal Cytokine Release Syndrome (CRS), a condition characterized by inflammation and hyperinflammation in the body following the death of numerous tumour cells. This is a common occurence as CAR-T cells are programmed to target and eliminate cancer cells.
Conclusion
NexCAR19’s authorization heralds a new era in India’s healthcare industry, positioning the country as a pioneer among developing nations with its own CAR-T and gene therapy platform. This evolution in treatment offers new promise for patients suffering from B-cell lymphomas, potentially revolutionizing cancer treatment in India.