The ethics of immunotherapy access: Beyond regulatory approvals in resource-constrained settings

India faces an unprecedented cancer burden, with an estimated 1.57 million new cases expected in 2025. [1]With one oncologist for every two thousand patients, the country is at the center of an ethical and access crisis.Despite remarkable advances in immuno-oncology, only 15-20% of eligible patients receive checkpoint inhibitors, largely because of economic, regulatory, and structural barriers. [2,3]This gap has created a silent epidemic of what may be described as systemic logistic toxicity.The impact is not only biological, but also economic and temporal.The cost of a single pembrolizumab cycle exceeds the annual income of nearly 70% of Indian households, earning <USD 3,000.Meanwhile, radiotherapy utilization remains at 28.5%, far below the Indian Council of Medical Research (ICMR) benchmark of 58.4%. [4,5]Such disparities can lead to treatment delays, denial, and preventable deaths. [6]is editorial is directed toward clinicians, administrators, and policymakers.It advocates an ethics-driven, low-dose immunotherapy model that combines affordability with scientific rigor.Access to cancer immunotherapy should not be a privilege determined by wealth but a right grounded in human dignity. THE EMERGING LOW DOSE PARADIGMIndia's strength in generic medicine production provides a solid foundation for flexible regulation and innovative approaches for affordable treatment.The central proposal is to adopt evidencebased, low-dose regimens under nationally regulated, off-label frameworks.This ensured transparency and fair access. [7,8]Promising examples at Tata Memorial Hospital with a low-dose nivolumab protocol using 20 mg every 3 weeks for advanced head-and-neck cancer achieved a 1-year overall survival of 43.4%, with a hazard ratio (HR) of 0.545.Cost savings reached 75% through vial-sharing strategies.Similarly, the All India Institute of Medical Sciences PLANeT trial using pembrolizumab 50 mg every 6 weeks in triple-negative breast cancer significantly improved pathological complete response rates with one-tenth the cost.This approach was recognized by the European Society for Medical Oncology 2025 as a model for resource-constrained settings. [9]ina's experience with domestically developed PD-1 inhibitors offers valuable lessons.They received 20 approvals and 80% local manufacturing.The adoption rates now exceed 70% at prices that are only 20-30% of those in the United States.For example, pembrolizumab costs approximately USD 2,492 in China compared to over USD 10,000 in the United States.