Expedited regulatory approval pathways for novel oncology drugs.

Authors

Vikesh Kumar Shukla, Akshma Chauhan, Krishnajit Malakar, Manshi Rana

Published in

Medical oncology (Northwood, London, England). Volume 43. Issue 8. Jul 03, 2026. Epub Jul 03, 2026.

Abstract

Expedited regulatory approval pathways are vital for providing timely patient access to novel therapies in oncology and other serious conditions. The traditional drug development pathway can take significant time, substantial costs (often more than ten years), and has a relatively low success rate. Programs such as the FDA's Accelerated Approval and Breakthrough Therapy, JP-PMDA's Sakigake Designation and Conditional Early Approval, AU-TGA's Priority Review and Provisional Approval, CDSCO's Accelerated Approval Mechanism and Emergency Use Authorization and the EMA's PRIME scheme, utilize mechanisms like rolling review and surrogate endpoints to accelerate development. The primary benefit of these pathways is significantly reducing the time to market for promising drugs, addressing critical unmet medical needs. However, this speed introduces challenges, including reliance on immature data from surrogate endpoints and frequent delays in completing mandatory confirmatory trials. Despite these limitations, expedited pathways have delivered important treatments for rare diseases like cancer, demonstrating their purpose as innovative accelerators. This review critically analyses the benefits, risks, and global variations of these pathways and provides recommendations to enhance their robustness, transparency, and international harmonization. To ensure that patients receive prudent, appropriate, and prompt treatments. This study concludes that a balanced strategy - integrating rigorous pre-market assessment with robust, enforced post-marketing surveillance - is essential to ensure these pathways deliver both rapid and beneficial patient outcomes.

PMID:
42397619
Bibliographic data and abstract were imported from PubMed on 03 Jul 2026.

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