People with EGFR-mutated lung cancer whose disease has progressed after Tagrisso or a similar pill are about six weeks from learning whether the FDA will approve ivonescimab with chemotherapy for them. The agency's target date is Nov. 14, Summit Therapeutics confirmed Sept. 28 as it announced a $2 billion equity investment from AstraZeneca. The drug is not approved in the United States, and the FDA can approve it, reject it, or extend its review.
For patients, the timing raises a practical question. Someone whose cancer is growing now may need to choose a next treatment before November, and waiting for an uncertain approval may not be safe.