India Approves Second CAR-T Cell Therapy
January 29, 2025
India’s Central Drugs Standard Control Organization (CDSCO)
recently approved varnimcabtagene autoleucel (var-cel), a CD 19-targeted chimeric antigen receptor (CAR) T-cell therapy, to treat adult patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma. Var-cel, marketed as Qartemi by Immuneel Therapeutics, received approval based on findings from the
phase 2 IMAGINE trial, which took place at hospitals throughout India and reported an 83.3% overall response rate at 90 days among patients who received the treatment.
The therapy is India’s second indigenously developed CAR T-cell therapy and the first in India to be benchmarked to global standards. Var-cel was licensed from Hospital Clínic de Barcelona (HCB), where preclinical and phase 1 studies took place.
Notably, var-cel will provide another affordable CAR T-cell therapy for patients in India, which faces a growing cancer burden. Immuneel expects the var-cel to cost around $60,000 per dose. In contrast, CAR T-therapies in the United States can cost upwards of $400,000 per dose.
