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CDSCO Approves CAR-T Cell Therapy for Leukaemia in India

The recent developments in cancer treatment have been monumental, with one of the most significant breakthroughs being CAR-T cell therapy. In a first for India, Immuno Adoptive Cell Therapy, an IIT Bombay-incubated company, has received approval from the Central Drugs Standard Control Organisation (CDSO) to use NexCAR19 (Actalycabtagene autoleucel), a humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) Therapy product. This approval allows for the treatment of relapsed or refractory B-cell Lymphomas and Leukaemia.

The Science Behind NexCAR19: A Collaborative Effort

The development of NexCAR19 is a testament to the advancements in science and technology in India. The result of a decade-long collaboration between IIT Bombay and Tata Memorial Centre (TMC), NexCAR19 underwent rigorous clinical investigations and translational studies before gaining approval.

Understanding CAR-T Cell Therapy

Unlike conventional treatments such as chemotherapy or immunotherapy which utilize drugs, CAR-T cell therapy leverages a patient’s own cells. T cells are extracted from the patient’s blood and modified in the laboratory, imbuing them with a special receptor that binds to specific proteins on the patient’s cancer cells. These modified T cells, now referred to as CAR T cells, are then grown in large numbers and reintroduced into the patient’s body. This unique method offers a higher specificity and stimulates the patient’s immune system directly to fight cancer—hence their epithet, “living drugs.”

Benefits and Challenges of CAR-T Cell Therapy

Despite its efficacy, the implementation and preparation of CAR T-cell therapy pose significant challenges. One of the biggest hurdles is the difficulty in preparing the therapies, which has limited their widespread use. Furthermore, while the therapy showcases high efficacy for certain types of cancers (up to 90%), its results are significantly lower for others. Another point of concern is the side-effected linked to this therapy, including cytokine release syndrome and neurological symptoms. Additionally, affordability remains a problem, with many critics arguing that CAR-T cell therapies may not be cost-effective.

T Cells and Their Role in the Immune System

T cells, or T lymphocytes, are essential components of our immune response. They are principally involved in cell-mediated immunity, aiding our bodies to recognize and respond to foreign substances such as viruses, bacteria, and abnormal cells, including cancer cells. There are two major kinds of T cells, Helper T cells and cytotoxic T cells, each playing a distinct role in the immune system.

Government Initiatives for Cancer Treatment in India

Taking into account the number of cancer cases in India, various Government initiatives have been launched. These include the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases, and Stroke; National Cancer Grid; and National Cancer Awareness Day. These initiatives aim at improving awareness, prevention, and control of cancer and providing affordable and accessible cancer treatment.

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