STAT+: FDA rejects lung cancer treatment ivonescimab from Summit Therapeutics

Nov. 15, 2026 Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street, and biotechnology. Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall Street, and biotechnology. He is also a co-host of the weekly biotech podcast The Readout Loud and author of the newsletter Adam’s Biotech Scorecard. You can reach Adam on Signal at stataf.54.The Food and Drug Administration rejected a treatment for a type of lung cancer developed by the U.S.-based biotech Summit Therapeutics and the Chinese drugmaker Akeso, Summit said on Sunday. In a letter sent to the companies, FDA regulators said the drug, called ivonescimab, could not be approved because it didn’t help patients live longer. While the drug was found to slow lung cancer worsening in patients, the absence of a survival benefit “does not support the positive benefit-risk profile in support of approval,” FDA reviewers concluded. The FDA’s rejection of ivonescimab is a regulatory setback for Summit, which oversees development of the drug outside of China, although one that was not entirely unforeseen. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe