India’s first cell therapy for cancer treatment receives regulatory approval
CAR-T cell therapy offers new hope for cancer patients in India at a fraction of the cost abroad
Mumbai: The Central Drugs Standard Control Organization (CDSCO) has issued market authorisation to CAR-T (Chimeric Antigen Receptor-T) cell therapy, a breakthrough treatment for treating relapsed/refractory (r/r) B-cell lymphomas and leukaemia, paving the way for its commercial launch of indigenous NexCAR19 in the country. ImmunoACT – an IIT Bombay incubated company – developed the treatment.
“We have received the market authorisation for our CAR-T cell therapy — NexCAR19. We are now waiting for a manufacturer licence from the state food and drugs administration for commercial usage,” Dr Rahul Purwar, founder and CEO of ImmunoACT, said.
Both ImmunoACT and Tata Memorial Centre (TMC) collaborated to invent indigenous CAR-T Cell Therapy – a type of cancer immunotherapy treatment that uses immune cells called T cells that are genetically altered in a laboratory to enable them to locate and destroy cancer cells more effectively.
Dr Purwar said the therapy offers new hope for patients in India and resource-limited countries. “With this, it has solidified India’s position among the elite group of nations with access to CAR-T therapy. Abroad, the CAR-T cell therapy costs around ₹3-4 crore per patient. The NexCAR19 will be ₹30-40 lakh per patient, which is 1/10th of the cost abroad. India sees 25,000 patients of B-Cell lymphomas every year,” he said, adding that the therapy would be available in around 20 government and private hospitals across most major cities.
Dr Hasmukh Jain, who oversaw the multicenter Phase I/II pivotal clinical trial involving 60 r/r B-cell lymphoma and leukaemia patients, said, “The results are nothing short of remarkable, with an approximate 70% overall response rate (ORR). It exhibits a favourable balance between efficacy and toxicity. This therapy is intended for patients with the CD19 marker in B cells, a protein used to diagnose cancers stemming from B cells, such as B cell lymphomas, acute lymphoblastic leukaemia, and chronic lymphocytic leukaemia.” The multicenter Phase I/II pivotal clinical trial saw the participation of 60 patients with r/r B-cell lymphomas and leukaemia.
While Dr Atharva Karulkar, Dr Alka Dwivedi, and a team led by Dr Purwar at IIT-Bombay played pivotal roles in its development, the clinical investigations and translational studies were led by Dr Hasmukh Jain and Dr Gaurav Narula, along with their teams at TMC.
Understanding CAR-T Cell Therapy
CAR-T cell therapy involves engineering a patient’s own immune cells in a laboratory to combat cancer. While it has demonstrated substantial effectiveness, particularly in blood cancers and lymphomas, ongoing research seeks to determine its role in treating solid tumours and autoimmune diseases such as lupus and multiple sclerosis.
Currently, this therapy is offered as a second-line treatment for late-stage leukaemia and lymphoma when patients do not respond to conventional treatments like chemotherapy and bone marrow transplants or experience relapsed cancer.