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CDSCO Approves India's 1st Living Drug '˜CAR'to Fight Cancer

Written by : Nikita Saha

October 17, 2023

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This advanced immunotherapy is designed for the treatment of leukemia and refractory or relapsed lymphoma (cancers of the lymph system).

Marking a significant milestone in the country's cancer care landscape, the Central Drugs Standard Control Organisation (CDSCO), has approved the first living drug called CAR (Chimeric Antigen Receptor) T-cell therapy. 

This advanced immunotherapy, developed by ImmunoACT, a company incubated at the Indian Institute of Technology Bombay, is designed for the treatment of leukemia and refractory or relapsed lymphoma (cancers of the lymph system).

CAR T-cell therapy is a type of treatment where a patient's own T cells (a type of white blood cell) are modified to recognize and attack cancer cells. However, as this advanced therapy uses a patient's own genetically engineered cell to target cancer, it is called a 'œliving drug'. 

Expressing his views, Rahul Purwar, CEO of ImmunoACT, said, 'œThe safety profile in terms of cytokine release syndrome (CRS) and absence of neurotoxicity indicates a significant improvement over the other commercially approved CD19-directed (type of T cells) CAR T-cell therapies,' he added.

The therapy by ImmunoACT, named NexCAR 19 (Actalycabtagene autoleucel), however, has been indigenously developed in collaboration with the Tata Memorial Centre (TMC).

Additionally, ImmunoACT has tied up with around 20 hospitals public and private in India so far, and patients have already started registering for the therapy. 

Going forward, the company aims to make this therapy available to Indian patients at about INR 30-40 lakh. Moreover, the clinical data from phases 1 and 2 indicates a nearly 70% overall response rate in about 60 patients, young adults, and adults in whom it was tested.

Immuneel Therapeutics is a biotech start-up backed by Biocon founders Kiran Mazumdar Shaw and US-based oncologist-author Dr Siddhartha Mukherjee, which has tested its CAR T-cell therapy in about 24 patients in India. Further, the company awaits market authorisation approval from the CDSCO.

Moreover, the researcher stressed that going ahead, CAR T-cell therapy has the potential to emerge as the fifth pillar of cancer care, after chemotherapy, surgery, radiation therapy, and targeted therapy.

In a recent development, CDSCO approved nine more medical device testing laboratories across India. As per the CDSCO, these laboratories conduct assessments and testing of medical devices on behalf of manufacturers, adhering to the guidelines specified in Form-MD-40 under the MDR, 2017.

Just days back, AstraZeneca India got CDSCO marketing approval for palivizumab, a preventive therapy for Respiratory Syncytial Virus (RSV). This virus is currently a major public health concern across the globe and is the second most common cause of death in children under the age of one. 


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