Commercial Availability of CAR-T Cell Therapy

Chimeric Antigen Receptor T-cell (CAR-T) therapy is a novel cancer treatment approach that utilizes a patient’s own T-cells to target and eliminate cancer cells. In November 2023, India approved its first indigenously developed CAR-T cell therapy product, NexCAR19, for commercial use in certain types of blood cancers. This milestone opens up access to this cutting-edge immunotherapy for cancer patients in India.

Background on CAR-T Cell Therapy

CAR-T cell therapy engineers a patient’s T-cells to express chimeric antigen receptors (CARs) that identify and bind target antigens on cancer cells, activating the CAR-T cells to proliferate and destroy cancerous cells. First, a patient’s T-cells are collected and genetically modified using viral vectors to introduce the CAR gene. These CAR-T cells are expanded in the laboratory. After lymphodepleting chemotherapy, the customized CAR-T cell product is infused back into the patient to multiply in vivo and attack cancer.

India Approves NexCAR19 for Commercial Use

India approved NexCAR19, its first indigenously developed CAR-T cell therapy product, on November 29, 2023. CDSCO granted market authorization to ImmunoACT, an IIT Bombay-incubated startup, for this therapy aimed at certain blood cancers. Specifically, NexCAR19 is approved for relapsed/refractory B-cell Acute Lymphoblastic Leukemia and Diffuse Large B-cell Lymphoma in adults. Researchers at IIT Bombay spent over a decade developing NexCAR19. Clinical trials showed >80% overall response rates in target patient groups, demonstrating NexCAR19’s ability to eliminate cancer cells and achieve remission.

Key Details on NexCAR19’s Approval

First Commercial Patient

In February 2024, just months after NexCAR19’s approval, Dr (Col) V.K. Gupta became one of the first patients to receive this CAR-T cell therapy commercially at Mumbai’s Tata Memorial Hospital.

Dr Gupta was suffering from diffuse large B-cell lymphoma (DLBCL) that had relapsed after earlier lines of treatment. As per reports, one month after the NexCAR19 infusion, evaluation showed Dr Gupta to be free of cancer cells.

This makes Dr Gupta the first patient treated commercially with Made-in-India CAR-T cells to achieve complete remission status. His treating oncologists have termed this outcome as “satisfactory”.

Significance for Indian Patients

The commercial approval of NexCAR19 brings this innovative immunotherapy within reach of Indian patients in need. Some key implications are:

• Expanded Access: NexCAR19’s commercial availability ends the lack of access for Indian patients to CAR-T cell therapy. Earlier, the only options were imported therapies costing Rs 3-5 crores per patient. Indigenous development makes this treatment more accessible and affordable.
• Customized for Indians: NexCAR19 has been customized for Indian conditions – developed using T-cells and viral vectors suited for Indian patients. This can improve its efficacy compared to therapies developed for foreign populations.
• Boosts Cancer Care Infrastructure: The processes for collecting, genetically modifying, expanding and infusing CAR-T cells require advanced infrastructure. NexCAR19’s commercialization will drive investments to upgrade cell therapy facilities in India.
• Technology Self-Reliance: NexCAR19 proves India’s scientific capabilities in biotechnology and cell therapy. Successful indigenous development of this complex therapy enhances India’s strength and self-reliance in healthcare innovations.

The Road Ahead

The commercial approval of NexCAR19 opens a new chapter in India’s cancer care landscape. However, there are still challenges to expand patient access and scale up this therapy across India.

Regulatory easements for developing advanced therapy infrastructure, trained manpower,andardized processes and reimbursement models will need to evolve. Wider clinical experience and data will clarify NexCAR19’s effectiveness over longer follow-up periods.