FDA Draft Guidance for Study Designs to Support Accelerated Approval: “The Bar Is Too Low”
On March 27, the Food and Drug Administration (FDA) released draft guidance geared toward sponsors of cancer drugs to provide recommendations for clinical trial designs that support accelerated approval. NBCC believes the bar is too low for accelerated approval; too many drugs are approved based on surrogate endpoints that fail to translate into clinically meaningful outcomes that matter to people, like living better or living longer.
On May 26, NBCC submitted comments on the draft guidance to the FDA and for the public record. NBCC is committed to FDA reform that ensures accelerated approvals are based on actual clinical benefit and robust clinical trial designs, not surrogate endpoints or weak single-arm trial designs.
Screening Mammography: Let Women Decide
On May 9, the United States Preventive Services Task Force (USPSTF) announced updated draft recommendations for breast cancer screening among women at average risk, making a blanket recommendation for biennial screening in women ages 40 to 74 years.
Whether mammography screening actually reduces deaths, particularly in younger women, has been debated for decades. At least seven prospective randomized controlled trials on the issue—the gold standard of evidence—did not resolve the matter. Now less robust—and less clear—methods of evidence, known as statistical modeling, are being used to demonstrate the benefits of early screening. Read NBCC’s full analysis.
2023 Advocate Leadership Summit Recap
During our annual Advocate Leadership Summit, advocates listened, learned, and questioned prominent breast cancer researchers about a range of important topics, including racial disparities in breast cancer, antibody-drug conjugates, the history of the treatment of breast cancer, the history of the FDA and Accelerated Approval, why researchers can cure cancer in mice but not humans, uninformative clinical trials, and the uses and limitations of circulating tumor DNA.
Political workshops supplemented advocates’ political toolkits with topics including how the Affordable Care Act affected access to health care, understanding your political power as a constituent, and NBCC advocacy for the DOD Breast Cancer Research Program.
Explore, download, and share pictures from the Summit.
Join Us in New York for this Year’s Women With Balls!
Join the National Breast Cancer Coalition Fund for its signature fundraising event Women With Balls® in NYC! Create or sponsor a team to participate on October 3.
The event features teams of bowlers competing for prizes while raising funds in support of NBCC in its mission to end breast cancer and save lives. Your support makes an impact in furthering NBCC’s innovative research and breast cancer advocacy education and training programs.
Can’t be in NYC in October? Create a team to bowl anywhere, anytime in support of NBCC.
The National Breast Cancer Coalition’s mission is to end breast cancer. Every dollar raised is immediately put to work by furthering scientific research, providing collaborative workshops and symposia, and advancing advocacy training and public policy work in Washington, DC, and in state capitals across the country.
Every minute counts in our efforts to achieve our mission of ending breast cancer. Every dollar equates to more lives saved. Your gift is more than a contribution. It is an investment that will enable us to end breast cancer once and for all.