CDSCO has approved CAR-T cell therapy for relapsed/refractory B-cell lymphomas and leukemia, paving the way for the commercial launch of NexCAR19, developed by Indian company ImmunoACT, incubated at IIT Bombay.

“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) joined forces to develop an indigenous CAR-T Cell Therapy, a form of cancer immunotherapy that involves genetically modifying T cells in a laboratory to enhance their ability to target and destroy cancer cells effectively.

Dr. Purwar expressed that this therapy brings newfound hope to patients in India and other resource-limited nations, positioning India among the select countries with access to CAR-T therapy. While CAR-T cell therapy abroad costs approximately ₹3-4 crore per patient, NexCAR19 will be priced at ₹30-40 lakh per patient, which is only a fraction of the cost overseas. India witnesses around 25,000 B-Cell lymphoma patients annually, and this therapy will be accessible in approximately 20 government and private hospitals across 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.”In the pivotal Phase I/II multicenter clinical trial, 60 patients with relapsed/refractory B-cell lymphomas and leukemia took part.

Dr. Atharva Karulkar, Dr. Alka Dwivedi, and a team under the leadership of Dr. Purwar at IIT Bombay made significant contributions to its development. Meanwhile, Dr. Hasmukh Jain and Dr. Gaurav Narula, along with their teams at Tata Memorial Centre (TMC), led the clinical investigations and translational studies.

CAR-T Cell Therapy

CAR-T cell therapy entails the modification of a patient's own immune cells in a lab to target cancer. Though it has shown significant efficacy, especially in blood cancers and lymphomas, continuous research aims to define its application in treating solid tumors and autoimmune conditions like lupus and multiple sclerosis.

At present, this therapy is administered as a secondary treatment for advanced leukemia and lymphoma, reserved for cases where conventional treatments like chemotherapy and bone marrow transplants fail to elicit a response or when cancer