Nov 15 (Reuters) – The US Food and Drug Administration on Sunday declined to approve Summit Therapeutics’ lung cancer drug ivonescimab, a setback for efforts to expand treatment for patients whose cancer has progressed after earlier therapies.
In its so-called complete response letter, the FDA cited a late-stage trial showing that, while ivonescimab significantly delayed disease progression, it did not demonstrate a statistically significant improvement in overall survival.
The decision follows the drug’s failure to achieve statistical significance on overall survival, a key measure of long-term treatment benefit, in a late-stage study that formed part of Summit’s marketing application.
The agency concluded that the progression-free survival benefit alone did not support a favorable benefit-risk profile for approval.
Summit has argued that longer follow-up supports the drug’s benefit, citing updated analyses that pointed to a lower risk of death across Western and Asian patient subgroups.
(Reporting by Padmanabhan Ananthan, Mariam Sunny, and Rishabh Jaiswal in Bengaluru; Editing by Tasim Zahid and Christina Fincher)
