Context: The Central Drugs Standard Control Organisation (CDSCO) has granted market authorisation for NexCAR19, India’s first indigenously-developed CAR-T cell therapy, to ImmunoACT, a company incubated by IIT Bombay.
- This paves the way for the commercial launch of the therapy in India, where it is expected to be available to cancer patients at a tenth of the cost abroad.
- For now, ImmunoACT has received CDSCO approval for use in patients aged 15 years and older.
What is CAR-T cell therapy?
- CAR-T is a revolutionary therapy that modifies immune cells, specifically T-cells, by turning them into potent cancer fighters known as CAR-T cells.
- T-cells are special cells (white blood cells that find and fight illness and infection) whose primary function is cytotoxic, meaning it can kill other cells.
- In CAR-T therapy, the T-cells are genetically modified into cancer-fighting cells. These supercharged cells are then put back into the body, and they kill cancer cells — especially in blood cancers like leukaemia and lymphomas.
- India is one of the first developing countries to have its indigenous CAR-T and gene therapy platform.
- NexCar19 is a type of CAR-T and gene therapy developed indigenously in India by ImmunoACT, which is a company incubated at IIT Bombay.
- The therapy 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 recognise and attach themselves to the cancer cells and start the process of elimination.
- The therapy is for people with B-cell lymphomas who did not respond to standard treatments like chemotherapy, leading to relapse or recurrence of the cancer.
- Recovery typically occurs within two weeks after one cycle of the treatment. In our data, approximately 70% of patients respond to the treatment, with variations between leukaemia and lymphoma cases.
- About 50% of these responsive patients achieve a complete response.
CAR-T therapy vs other treatments:
- While chemotherapy and immunotherapy may add a few months or years to a cancer patient’s life, cell-and-gene therapy is designed to cure and provide lifelong benefit.
- It makes treatment easier with a one-time therapy [unlike several sessions of chemotherapy] that can be truly transformative for a patient. It is a lifeline for non-responsive cancer patients.