The first CAR-T cell therapy for blood cancer in India is approved by the CDSCO
By MYBRANDBOOK
Backed by Laurus Labs and IIT-Bombay, ImmunoACT received approval by the Central Drugs Standard Control Organisation (CDSCO) for the treatment of relapsed/refractory B-cell lymphomas and leukaemia which is called NexCAR19 (Actalycabtagene autoleucel), India's first CAR-T (Chimeric Antigen Receptor T cell therapy. NexCAR19 a CD19-targeted CAR-T cell treatment is a ground-breaking product created in India that represents a significant development in cell and gene therapy.
Immunoadoptive Cell Therapy Private Limited ("ImmunoACT") received the marketing authorization approval for the first humanized CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory (r/r) B-cell lymphomas and leukemia in India.
NexCAR19 is the culmination of a collaborative effort across a decade, between the IIT- Bombay, and Tata Memorial Centre (TMC). Dr Atharva Karulkar, Dr Alka Dwivedi and the team led by Dr 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 TMH.
The clinical trial, led by Dr Hasmukh Jain, was conducted with 60 patients of r/r B-cell lymphomas and leukemia. The clinical data indicates approximately 70 percent overall response rate (ORR). The safety profile in terms of cytokine release syndrome (CRS) and absence of neurotoxicity indicates a significant improvement over the other commercially approved CD19-directed CAR-T cell therapies.
Dr Hasmukh Jain noted, "NexCAR19 has shown an excellent balance of efficacy and low toxicity, which is a significant advantage in clinical management (post-infusion) of the patients in our resource-constrained settings".
Singapore to remove One-Time Passwords from Bank Accounts
According to the Monetary Authority of Singapore, clients who utilise secur...
Is 375 million Airtel subscribers database breached?
When a hacker claims to have accessed and put up for sale a customer databa...
The government of India intends to construct a single portal f
A single portal will be launched by the Indian government to list all of it...
OpenAI offers GPT-4o, a faster model available to all users at
GPT-4o, a faster and more sophisticated AI model, is made available to all...
Icons Of India : Girish Mathrubootham
Girish Mathrubootham is the Founder of Freshworks (previously known ...
ICONS OF INDIA : SANJAY GUPTA
Sanjay Gupta is the Country Head and Vice President of Google India an...
ICONS OF INDIA : S KRISHNAN
S Krishnan as the secretary for the electronics and information techno...
IREDA - Indian Renewable Energy Development Agency Limited
IREDA is a specialized financial institution in India that facilitates...
PFC - Power Finance Corporation Ltd
PFC is a leading financial institution in India specializing in power ...
BEL - Bharat Electronics Limited
BEL is an Indian Government-owned aerospace and defence electronics co...
Indian Tech Talent Excelling The Tech World - Thomas Kurian, CEO- Google Cloud
Thomas Kurian, the CEO of Google Cloud, has been instrumental in expan...
Indian Tech Talent Excelling The Tech World - Aneel Bhusri, CEO, Workday
Aneel Bhusri, Co-Founder and Executive Chair at Workday, has been a le...
Indian Tech Talent Excelling The Tech World - Anirudh Devgan , President, Cadence Design
Anirudh Devgan, the Global President and CEO of Cadence Design Systems...