WCLC: Impact of Time to Drug Approval on Potential Years of Life Lost
Every hour lost to the cancer drug regulatory process costs 29 life-years lost in the United States and 260 life-years worldwide, according to research (Abstract ORAL12.05) presented on September 7 at the 16th World Conference on Lung Cancer hosted by the International Association of the Study of Lung Cancer in Denver, Colorado.
David Stewart, MD, FRCPC, Head of the Division of Medical Oncology at the University of Ottawa/The Ottawa Hospital, presented data on how the regulatory process of new therapies slows progress by increasing drug development costs and producing speed bumps that delay approval of useful drugs. This process also increases resources required to document that other agents are ineffective.
Study Findings
Dr. Stewart and his team assessed cancer therapies undergoing phase III trials between 2001 and 2015. To be included, trials had to document statistically significant improvement in overall survival. Adjuvant trials and trials in uncommon malignancies were excluded. To determine the number of life-years potentially lost per year required for drug approval, Dr. Stewart multiplied the improvement in median survival in years by the estimated number of patients (North American and worldwide) dying annually from the relevant malignancy.
When the combined impact of all tumor sites and drugs is considered together, there were 29 life-years lost in North America per hour of delay in therapy approval (1 for every 2 minutes of delay) and 260 life-years lost worldwide per hour of delay (1 for every 14 seconds of delay).
Undeniable Impact
Dr. Stewart hopes his research will call attention to the adverse impact regulatory delays create.
“Clearly, the survival gains associated with the foregoing drugs are only modest,” Dr. Stewart said. “However, there would be a large negative impact associated with approval delays even if factors such as comorbidities, performance status, ability to pay, etc, limit the number of patients treated to a fraction of the total dying from a specific malignancy.”
Dr. Stewart stressed that there are numerous opportunities to improve efficiency of cancer drug approval without sacrificing safety or data integrity. “These numbers do not take into account impact of drugs nonevaluable due to crossover or missing survival data, drugs that were prematurely abandoned, drugs still undergoing investigation, or approaches for nonmalignant lethal diseases,” Dr. Stewart said.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
