FDA Expands Approval of Durvalumab to Reduce the Risk of NSCLC Progression


On February 16, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) for the treatment of patients with stage III unresectable non–small cell lung cancer (NSCLC) whose cancer has not progressed after treatment with chemoradiation.

“This is the first treatment approved for stage III unresectable non–small cell lung cancer to reduce the risk of the cancer progressing, when the cancer has not worsened after chemoradiation,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “For patients with stage III lung cancer that cannot be removed surgically, the current approach to prevent progression is chemoradiation. Although a small number of patients may be cured with the chemoradiation, the cancer may eventually progress. Patients now have an approved therapy that has been shown to keep the cancer from progressing for a longer time after chemoradiation.”

Durvalumab targets the programmed cell death protein 1 (PD-1)/programmed cell death-ligand 1 (PD-L1) pathway. By blocking these interactions, durvalumab may help the body’s immune system attack cancer cells.

Durvalumab was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic bladder cancer.


The approval of durvalumab for the treatment of stage III, unresectable NSCLC was based on the randomized PACIFIC trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. The trial measured the length of time until progression-free survival. The median progression-free survival for patients taking durvalumab 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 overall survival following treatment with durvalumab after chemotherapy and radiation.

Common side effects of durvalumab in patients with stage III unresectable NSCLC include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.

Serious risks of durvalumab include immune-mediated side effects such as pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis. Other serious side effects of durvalumab include infection and infusion-related reactions. Durvalumab can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.

The FDA granted this application Priority Review and Breakthrough Therapy designations. 

The FDA granted the approval of Imfinzi to AstraZeneca.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.