DCGI Approves NexCar19 Therapy For Commercial Use, Offering Relief To Blood Cancer Patients In India

Drug Controller General of India has approved a new CAR-T cell therapy for commercial use to treat relapsed-refractory B-cell lymphoma and leukemia. 

Ritika Sakhuja
Written by: Ritika SakhujaUpdated at: Oct 14, 2023 12:48 IST
DCGI Approves NexCar19 Therapy For Commercial Use, Offering Relief To Blood Cancer Patients In India

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In a winning move, the Drug Controller General of India (DCGI) has approved a new CAR-T (Chimeric Antigen Receptor-T) cell therapy for commercial use to treat blood cancer. The therapy called NexCar19 has been approved for relapsed-refractory B-cell lymphoma and leukaemia. Explaining what 'relapsed' and 'refractory' mean in terms of lymphoma, the Lymphoma Research Foundation shared that 'relapsed' is used for a disease that has reappeared after remission, and 'refractory' is used when 'the lymphoma does not respond to treatment (meaning that the cancer cells continue to grow) or when the response to treatment does not last very long.'

Breakthrough Treatment For Blood Cancer In India

DCGI Blood Cancer Treatment

This new CAR-T cell therapy has been developed by ImmunoACT, a spinoff of IIT-Bombay. Earlier, lymphoma and leukaemia patients had to travel abroad to get this cutting-edge therapy, usually to the United States, where this therapy was launched in 2017 and cost over Rs 3.3 crore as per media reports. But with this new launch, thousands of patients can get treated right here at home. 

This was a much-anticipated move because according to the National Cancer Institute, the estimated number of cases in India is 59,610 for leukaemia and 80,550 for non-Hodgkin’s lymphoma.

Rahul Purwar, CEO, of ImmunoACT, shared that this new therapy will be available to blood cancer patients from today onwards, at almost 20 government and private hospitals, and will cost around Rs 30-35 lakh per patient.

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The treatment has also received approval from the Central Drugs Standards and Control Organisation (CDSCO), the central drug authority, after assessing data from phase 1 and 2 clinical trials of NexCar19, which exhibited a 70% overall response rate, and a significant improvement in safety profile as compared to previously available Car-T cell therapies. 

What is CAR-T cell therapy? 

DCGI Blood Cancer Treatment

Simplifying the data provided by the National Centre For Biotechnology Information, imagine your body has an army of special soldiers called T-cells that can fight diseases, including cancer. Scientists have found a way to supercharge these T-cells using something called Chimeric Antigen Receptors or CARs.

T-cells are a type of white blood cells called lymphocytes that help your immune system fight diseases. These CARs are like special sensors that help the T-cells recognise cancer cells. When the T-cells with CARs find a cancer cell, they get activated to attack it. 

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There are different CAR therapies. This new NexCar19 will target a protein called CD19 found in cancer cells and some normal cells. As of now, CAR-T cell therapy is usually offered as a second-line of treatment for late-stage blood cancer when patients are either not responding to chemotherapy and bone marrow transplant, or their cancers have relapsed.

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