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.

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.

Related Posts

FSSAI suspends licence of Dior Pharmaceuticals for violations at nutraceutical plant

New Delhi: Food regulator FSSAI has suspended the licence of Dior Pharmaceuticals for multiple violations at its nutraceutical factory. In a social media post on Thursday, FSSAI observed “serious non-compliances”…

Haryana intensifies crackdown on spurious drugs, FDA records 16 arrests in 10 months

Additional chief secretary (ACS), health, Sumita Misra said of these, 12 arrests have been made by FDA, Gurugram, which has also busted multiple interstate counterfeit medicine syndicates, seized fake medicines…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

FSSAI suspends licence of Dior Pharmaceuticals for violations at nutraceutical plant

FSSAI suspends licence of Dior Pharmaceuticals for violations at nutraceutical plant

Haryana intensifies crackdown on spurious drugs, FDA records 16 arrests in 10 months

Haryana intensifies crackdown on spurious drugs, FDA records 16 arrests in 10 months

FSSAI Issues Prohibition Orders against FOLINEURO Syrup and Neuherbs TRUE VITAMIN over Misleading Claims

FSSAI Issues Prohibition Orders against FOLINEURO Syrup and Neuherbs TRUE VITAMIN over Misleading Claims

Pune Police Bust Illegal Bodybuilding Drug Racket, 5 Arrested; 50 Mephentermine Injections Seized In Major Crackdown

Pune Police Bust Illegal Bodybuilding Drug Racket, 5 Arrested; 50 Mephentermine Injections Seized In Major Crackdown

Piramal Pharma eyes mid-teens growth in FY27, prioritises organic expansion

Piramal Pharma eyes mid-teens growth in FY27, prioritises organic expansion

13 Years after Oxytocin Order, HC Seeks Compilance Status

13 Years after Oxytocin Order, HC Seeks Compilance Status