Immunoadoptive Cell Therapy Private Limited (ImmunoACT) has been granted approval for NexCAR19, its CAR-T therapy, by the Central Drug Standards Control Organisation of India. NexCAR19 is intended for the treatment of relapsed or refractory B-cell lymphomas and leukemia, and its approval ushers in the first indigenous CAR-T cell therapy in India.
The approval was granted after a Phase I/II trial involving 60 patients, which resulted in a 70% overall response rate and a considerable delay in cancer progression. Despite this, the therapy, priced between INR 30-40 lakh ($36,000-$48,000), remains beyond the reach of many due to its cost.
There are additional concerns about the availability of specialized facilities and expert staff required to administer the therapy. These resources are mostly concentrated in major cities. In the future, ImmunoACT may face competition from Immuneel Therapeutics’ CAR-T therapy, currently in Phase II development.
Access and affordability are significant challenges when it comes to critical treatments in India’s healthcare sector. These issues pose a hurdle to the acceptance and widespread use of life-saving therapies, such as NexCAR19. It is noteworthy that India has been grappling with a high prevalence of B-cell lymphomas and leukemia, and such advanced therapies can be a game-changer if made more accessible and affordable.
Despite the approval of ImmunoACT’s NexCAR19 as a treatment for relapsed or refractory B-cell lymphomas and leukemia, its high cost and limited availability of required resources pose significant challenges to its widespread use. The introduction of the first indigenous CAR-T cell therapy in India is a significant step forward, but there is a pressing need to address these barriers to ensure that more patients can benefit from such advanced treatments.
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