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

Kota Maternal Deaths: Jaipur Expert Team Finds Sterilization and Fumigation Lapses; FDA Collects Samples, Collector Orders Action

Jaipur:  The investigation into the deaths and critical illness of women following Caesarean deliveries at Kota’s government hospital has intensified, with a high-level medical team from Jaipur reportedly identifying serious…

Prescription Drug Diversion Crisis Deepens Across India: Massive Seizures of Pregabalin, Tramadol, Codeine Syrup and Psychotropic Capsules Expose Regulatory Failure

New Delhi: Despite stringent provisions under the Drugs and Cosmetics Act, 1940 and the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, illegal diversion and trafficking of prescription medicines continues…

Leave a Reply

Your email address will not be published.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

You Missed

Kota Maternal Deaths: Jaipur Expert Team Finds Sterilization and Fumigation Lapses; FDA Collects Samples, Collector Orders Action

Kota Maternal Deaths: Jaipur Expert Team Finds Sterilization and Fumigation Lapses; FDA Collects Samples, Collector Orders Action

Prescription Drug Diversion Crisis Deepens Across India: Massive Seizures of Pregabalin, Tramadol, Codeine Syrup and Psychotropic Capsules Expose Regulatory Failure

Prescription Drug Diversion Crisis Deepens Across India: Massive Seizures of Pregabalin, Tramadol, Codeine Syrup and Psychotropic Capsules Expose Regulatory Failure

US FDA and Telangana DCA bolster global pharma safety at second regulatory forum

US FDA and Telangana DCA bolster global pharma safety at second regulatory forum

Nishant as Health Minister, Bihar is all set to witness a New Dawn of Healthcare

Nishant as Health Minister, Bihar is all set to witness a New Dawn of Healthcare

Six Women Develop Serious Complications After C-Section

Six Women Develop Serious Complications After C-Section

Cracks Down on Pharma Biological Firm in Bagru; Labeling Violations, Unapproved Claims and Quality Lapses Detected

Cracks Down on Pharma Biological Firm in Bagru; Labeling Violations, Unapproved Claims and Quality Lapses Detected