Why is it in the news?
- NexCAR19 is India’s first indigenously-developed CAR-T cell therapy developed by ImmunoACT, incubated at IIT Bombay.
- It was recently authorized by the Central Drugs Standard Control Organisation (CDSCO).
About CAR-T Cell Therapy
- CAR T-cell therapies are a major breakthrough in cancer treatment.
- Unlike chemotherapy or immunotherapy which involve taking drugs, CAR T-cell therapies use a patient’s own cells. They are modified in the laboratory to activate T-cells and target tumor cells.
- CAR T-cell therapy has been approved for leukaemias (cancers arising from the cells that produce white blood cells) and lymphomas (arising from the lymphatic system).
- Other treatments like chemotherapy might extend life by months or years. However, CAR-T therapy aims for a cure and lifelong benefit.
- CAR-T offers a one-time transformative treatment, especially beneficial for non-responsive cancer patients.
- The therapy also results in minimal Cytokine Release Syndrome (CRS), which is characterized by inflammation and hyperinflammation in the body due to the death of a significant number of tumor cells, as CAR-T cells are designed to target and eliminate cancer cells.
- NexCar19 is a type of CAR-T and gene therapy developed indigenously in India.
- It is designed to target cancer cells that carry the CD19 protein. This protein acts like a flag on cancer cells, which allows CAR-T cells to recognize and attach themselves to the cancer cells and start the process of elimination.
- Even some developed nations don’t have their own CAR-T therapies; they import them from the United States or Europe. India is now one of the first developing countries to have its indigenous CAR-T and gene therapy platform.
Eligibility for NexCAR19
- Targets patients with B-cell lymphomas unresponsive to standard treatments.
- Process: Doctor’s prescription -> Blood donation -> Genetically modification in the lab -> Reinfusion in 7-10 days.
- Post-treatment recovery in approximately two weeks.
- About 70% patients respond and 50% of these achieve a complete response.
- B-cell leukaemia is common among children.
- Paediatric trial phase is currently underway at Tata Memorial Hospital.
- It is currently approved for patients aged 15 years and older.
Availability in India
- Licensing and hospital onboarding is in progress.
- Partnered with major hospitals like Tata Hospital, Nanavati, Fortis, and others.
- Estimated cost is about Rs 30-40 lakh. The goal is to reduce it to Rs 10-20 lakh as technology and processes mature.
- Typically, therapies approved by agencies like CDSCO should be covered by insurance and given the high cost, coverage specifics might vary.