16 February 2018 - The U.S. FDA today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer whose tumoors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation).

The approval of Imfinzi for the treatment of stage III, unresectable non-small-cell lung cancer was based on a randomised trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. The trial measured the length of time the tumors did not have significant growth after starting treatment with Imfinzi or a placebo (progression-free survival). The median progression-free survival for patients taking Imfinzi was 16.8 months compared to 5.6 months for patients receiving a placebo. In addition, the sponsor has agreed to a post-marketing commitment to provide additional information from their study to the FDA about how long patients lived following treatment with Imfinzi after chemotherapy and radiation (overall survival).

The FDA granted this application priority review and breakthrough therapy designations. 

Read FDA press release