The ethics of immunotherapy access: Beyond regulatory approvals in resource-constrained settings
Year: 2025
Type: article
Abstract: India'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] China'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.
Authors: Karan Sood, Prashant Mehta
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7117356074