All about CAR T-cell therapy, India’s 1st ‘living drug’ that uses patient’s own genetically engineered cells to fight cancer
Source: The Print
Patients already registering for CAR T-cell therapy, developed indigenously by ImmunoACT under the name NexCAR19. It will be used to treat leukemia & refractory or relapsed lymphoma.
New Delhi: Last week, the first ‘living drug’ in India received approval, marking a significant milestone in the country’s cancer care landscape.
The Central Drugs Standard Control Organisation (CDSCO), on 13 October, approved the first CAR (Chimeric Antigen Receptor) T-cell therapy — a cutting-edge immunotherapy developed by ImmunoACT, a company incubated at the Indian Institute of Technology Bombay, for the treatment of leukemia and refractory or relapsed lymphoma (cancers of the lymph system).
CAR T-cell therapy for treating specific types of cancer was first approved in the US in 2017 and, as of now, 6 therapies by various drugmakers have been approved by the US Food and Drug Administration (FDA). Since the therapy uses a patient’s own genetically engineered cell to target cancer, it is also called a “living drug”.
In the US, this therapy costs about $400,000 or nearly Rs 3.3 crore, for every patient.
The therapy by ImmunoACT, named NexCAR 19 (Actalycabtagene autoleucel), however, has been indigenously developed in collaboration with the Tata Memorial Centre (TMC).
ImmunoACT has tied up with around 20 hospitals — public and private — in India so far, and patients are already registering for the therapy. The company plans to make it available to Indian patients at about Rs 30-40 lakh. Its CEO Rahul Purwar told ThePrint that the clinical data from phase 1 and 2 indicates nearly 70 percent overall response rate in about 60 patients — young adults and adults — in whom it was tested.
“The 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.
Immuneel Therapeutics — a biotech start-up backed by Biocon founder 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, is also waiting for the market authorisation of the product from the CDSCO, sources told ThePrint.
ThePrint explains how this novel therapy works, how NexCAR 19 is different from other CART T-cell therapies available in developed countries, what may be therapy’s limitations and significance in cancer care regime.
