What was the committee asked to consider? On April 30, 2026, the U.S. Food and Drug Administration (FDA) convened the Oncologic Drugs Advisory Committee (ODAC) to consider the benefits and risks of two regimens for treatment of cancer. The morning session focused on the results of the SERENA-6 trial, which was intended to support a new…
On April 7, Friends of Cancer Research (Friends) hosted a public meeting, “Application of External Control Arms in Oncology Drug Development” to explore opportunities to advance the use of external control arms (ECAs) in oncology drug development. ECAs are constructed from external data sources, such as prior clinical trials or real-world data (RWD), and can provide valuable comparative evidence for evaluating new therapies, particularly when traditional randomized controlled…
Friends of Cancer Research (Friends) convened a multidisciplinary working group to examine how to incorporate artificial intelligence (AI) into tumor assessment workflows in oncology clinical trials. The group developed a white paper exploring the potential of emerging AI-enabled tools to enhance tumor assessment, as well as key considerations for the adoption and regulatory approval of AI-enabled imaging endpoints that…
Friends’ recent circulating tumor DNA (ctDNA) study examined 8 clinical trials including 940 patients with advanced non-small cell lung cancer (aNSCLC) treated with tyrosine kinase inhibitors (TKI) to assess whether changes in ctDNA levels could serve as an early indicator of overall survival (OS) and progression-free survival (PFS). The study investigated the association between ctDNA…
Chevron deference was established by the 1984 Supreme Court of the United States (SCOTUS) case of Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., which related to EPA’s ability to regulate air quality under the Clean Air Act. The decision mandated that federal courts defer to federal agency’s reasonable interpretation of ambiguous statutes…
