Analyzing Accelerated Approval for Oncology Drugs: NPC Commentary Evaluates Evidence on FDA Program Effectiveness, Concludes Benefits Outweigh Risks
A new publication in AJMC examines evidence regarding the clinical benefit of the FDA’s Accelerated Approval Program and finds it is working for patients
For immediate release: August 13, 2024
Contact: Michael Pratt, 202-827-2088, [email protected]
Washington, DC – Today in the American Journal of Managed Care, NPC’s Julie Patterson, John M. O’Brien, and Jon D. Campbell author a new analysis supporting the FDA’s conclusion that the Accelerated Approval (AA) Program is successfully working to address unmet medical needs.
The commentary, “The Accelerated Approval Program for Oncology Drugs: Celebrating More Than 250,000 Life-Years Gained and Counting,” evaluates two recent studies from the Journal of the National Comprehensive Cancer Network (JNCCN) and the Journal of the American Medical Association (JAMA) — both of which aimed to estimate the AA Program’s clinical benefit by analyzing the impact of AA oncology drugs on overall survival, yet came to different conclusions.
“Despite overlapping samples, the JAMA study took a narrow, drug-level approach to assess clinical benefit as statistical superiority over the standard of care for overall survival or global quality of life,” explained Dr. Patterson, “while the JNCCN study reported a patient-level summation of the estimated life-years gained because new AA drugs were available sooner.”
“Because of AA, patients and their clinicians have treatment options earlier than they otherwise would,” said the authors, “and this has likely led to more than 250,000 life-years gained in patients with cancer… The evidence suggests that the benefits of the AA Program — namely, expedited access to new drugs for patients with serious conditions and high unmet medical need — outweigh its risks.”
About the National Pharmaceutical Council
The National Pharmaceutical Council (NPC) is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation's major research-based pharmaceutical companies, NPC focuses on research development, information dissemination and education on the critical issues of evidence, innovation, and the value of medicines for patients. For more information, visit www.npcnow.org and follow NPC on LinkedIn.
About the American Journal of Managed Care
Founded in 1995, the American Journal of Managed Care® (AJMC®; ISSN 1096-1860) provides an independent, international forum for peer-reviewed literature on healthcare outcomes research, disseminating clinical information to managed care professionals, clinical decision makers, and other healthcare professionals involved in the access and utilization of healthcare resources. It is a monthly publication with a 2022 impact factor of 3.2 that circulates to approximately 30,000 individuals around the world.
Website | LinkedIn