CDSCO approves India's first CAR-T cell therapy against certain blood cancers

ImmunoACT is an IIT Bombay incubated company-backed by drug maker Laurus Labs on Friday said it has received approval from Indian drug regulator the Central Drugs Standard Control Organization (CDSCO) for its CAR-T cell therapy NexCAR19 (actalycabtagene autoleucel), for the treatment of certain types of blood cancers.

NexCAR19 will be the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T) therapy indigenously developed in India to be approved.

NexCAR19 will be used for treating relapsed/refractory (r/r) B-cell lymphomas and leukemia in India.


ImmunoACT didn't reveal the pricing of the drug, but said it intends to make the NexCAR19 available to its partner hospitals as soon as possible.

ImmunoACT's founder and CEO Rahul Purwar has in the past announced that its CAR-T cell therapy would be priced anywhere between Rs 30 lakh and Rs 40 lakh per patient, a lot cheaper compared to existing treatments. Each patient's CAR-T cell therapy costs 3-4 crore (INR).

The multi-center phase I/II pivotal clinical trial, led by Dr Hasmukh Jain, was conducted with 60 patients of r/r B-cell lymphomas and leukemia.

The clinical data indicates 70% overall response rate (ORR). The safety profile in terms of cytokine release syndrome (CRS) and low-toxicity indicating a significant improvement over the other
commercially approved CD19-directed CAR-T cell therapies.

NexCAR19 is a collaborative effort across a decade, between the IIT-Bombay, and Tata Memorial Centre (TMC). Atharva Karulkar, Alka Dwivedi and the team led by Rahul Purwar, associate professor at IIT Bombay designed and developed the NexCAR19, which subsequently underwent integrative process development & manufacturing under cGMP at ImmunoACT.

Clinical investigations and translational studies were led by Dr Hasmukh Jain and Dr Gaurav Narula and their teams at Tata Memorial Hospitals.

“Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost," said Purwar, Founder and CEO of ImmunoACT.

"In terms of technical achievement, this is comparable to the moon shot and it puts India on the elite list of select countries that have access to CAR-T therapy,” Purwar added.

Hyderabad-based drug maker Laurus Labs has been the early backer of ImmunoACT and has invested over $18 million to support ImmunoACT to scale its R&D and commercialization efforts.