Summit Seeks Cancer Drug’s Approval Despite US Regulator Warning

Summit Therapeutics Inc. plans to file for approval for its closely watched lung cancer treatment by the end of this year, even though US drug regulators already warned the company it doesn’t have strong enough data.

Summit said Monday it’ll seek FDA clearance based on results of a late-stage trial that compared a combination of its drug, ivonescimab, and chemotherapy with a placebo and chemotherapy. Participants who took Summit’s drug saw improvements in a measure of tumor growth called “progression-free survival.”

But follow-up data hasn’t shown the drug helps patients live longer, known as overall survival, which is a key ...