"As nearly 40,000 oncology professionals from around the world gather in Chicago for the 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO) to learn about the latest in clinical cancer research — from new treatment options and advances in precision medicine to insight for improving access to care — ASCO welcomes the U.S. Food and Drug Administration's (FDA) announcement that it is advancing new policies to make the drug review and approval process more modern, more scientifically rigorous, and more efficient.
Today, FDA Commissioner Scott Gottlieb, MD, shared with meeting attendees the agency's plans to provide additional guidance to sponsors about including more under-represented patients in clinical trials. Long a priority for the society, ASCO has proposed broadening clinical trial eligibility criteria and has appreciated the opportunity to work closely with FDA on this critical issue.
ASCO also commends the agency for its efforts to reduce the number of cancer deaths caused by cigarette smoking, and we are very encouraged by Dr. Gottlieb's comments about regulating nicotine levels in cigarettes and regulating the use and sale of e-cigarettes to youth and young adults. We look forward to FDA implementing its rule to regulate e-cigarettes, cigars, and other tobacco products.
Finally, we were delighted to hear about the new Oncology Center of Excellence (OCE) Real Time Oncology Review (RTOR) pilot, which will ensure that data review occurs at the beginning of the review process — adding significant efficiencies to the drug application system. This enhancement will allow quality issues to be identified earlier, so that reviews can proceed in a more timely fashion resulting in clinical data that is most important to treatment decisions by patients and physicians.
ASCO continues to support the critical work of FDA and our shared goal to ensure that every individual with cancer receives safe and effective treatment."