Abstract
Chimeric antigen receptor (CAR) T therapy has become a transformative treatment for relapsed and refractory (r/r) B-cell malignancies, now standard in high-income countries. Until recently, the access and availability of CAR-T therapy in low-and middle-income countries (LMICs) was constrained by exorbitant costs, poor infrastructure, inadequate training, and regulatory complexities. We share insights from implementing talicabtagene autoleucel (Tali-cel) in real-world settings. Tali-cel, India’s first homegrown CAR-T therapy developed through academic-industry collaboration, received marketing authorization in October 2023. This review consolidates evidence supporting its rollout, focusing on manufacturing innovation, clinical performance, safety management, and policy mechanisms influencing access. The program is built on a vertically integrated platform with a centralized hub-and-spoke network of over 80 centers. This model ensured operational reliability while reducing treatment cost to ∼USD 30,000, only 6–8% of Western list prices. In pivotal trials, Tali-cel achieved overall response rates (ORR) of 73% in r/r B-ALL and 72% in r/r B-NHL, with a favorable safety profile. Real-world data further confirmed efficacy, with ORR of 89% in r/r B-ALL and 70% in r/r B-NHL. Safety outcomes were notable, with ICU admission required in only 8% of cases and minimal ICANS incidence. Beyond clinical performance, this progress shows how LMICs can expand access by combining innovation with policies like insurance coverage, public funding, and digital tools. Tali-cel demonstrates how advanced therapies can be scaled in cost-sensitive environments, offering a model for other resource-constrained health systems to reduce inequities and improve access to next-generation cancer therapies.
