FDA Rejects Lung Cancer Drug Ivonescimab From Summit Therapeutics
By Dr. Zubair Khalid, DVM, MS, PhD ·
The U.S. Food and Drug Administration has rejected ivonescimab, a treatment for a type of lung cancer developed by U.S. biotechnology company Summit Therapeutics and Chinese drugmaker Akeso. The decision was announced November 15, 2026.
Ivonescimab was being developed as a potential therapy for non-small cell lung cancer. The FDA’s rejection means the drug cannot currently be marketed or sold in the United States. The specific reasons for the rejection were not detailed in the announcement.
Summit Therapeutics, based in Menlo Park, California, partnered with Akeso, a Chinese biopharmaceutical firm, to develop the drug. The treatment had been under regulatory review following clinical trial data submitted to the agency.
Context
Lung cancer remains the leading cause of cancer death worldwide, and non-small cell lung cancer accounts for the majority of cases. New treatment options are urgently needed, particularly for patients who do not respond to existing immunotherapies or targeted therapies. The FDA’s rejection of ivonescimab highlights the high bar for regulatory approval in oncology and the challenges that biotech companies face when bringing novel drug candidates from preclinical research through clinical trials and into the clinic. The decision also underscores the complexities of cross-border drug development partnerships between U.S. and Chinese firms, which have drawn increased regulatory scrutiny in recent years.
Source: original report