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FDA Approves Imfinzi for Stage III NSCLC

The U.S. Food and Drug Administration (FDA) had approved Imfinzi (durvalumab) for treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors cannot be removed with surgery and whose cancer has not progressed after chemotherapy and radiation.1

Imfinzi is an immunotherapy that targets the PD-1/PD-L1 pathway. Imfinzi is currently approved for the treatment of bladder cancer.

What the Research Shows

The approval of Imfinzi comes after promising results from the PACIFIC clinical trial. In this trial, which included 713 patients, Imfinzi demonstrated an improvement in progression-free survival of 11.2 months, compared to placebo. Progression-free survival is defined as the length of time during and after treatment that a patient lives with the disease but it does not get worse. This represents a 48% reduction in relative risk of progression or death vs. placebo in all patients, regardless of PD-L1 status. The PACIFIC trial is currently ongoing to evaluate overall survival.2

“Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients.” said Scott J. Antonia, MD, Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa and investigator in the PACIFIC trial.3

A New Treatment Option

“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.” said Richard Pazdur, M.D., 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.1

Common side effects of Imfinzi in patients with stage III unresectable NSCLC include cough, fatigue, inflammation in the lungs, upper respiratory tract infections, difficulty breathing, and rash. Imfinzi may cause harm to a developing fetus. Women should be aware of the potential risks to the fetus and to use contraception while taking Imfinzi.1 The full prescribing information for Imfinzi can be found here.

  1. FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing. US Food and Drug Administration Press Announcements. Available at:
  2. Durvalumab after Chemoradiotherapy in Stage III Non–Small-Cell Lung Cancer. Antonia, S. et. al. N Engl J Med 2017; 377:1919-1929 DOI: 10.1056/NEJMoa1709937. Available at:
  3. US FDA approves Imfinzi for unresectable Stage III non-small cell lung cancer. Astra Zeneca Media Release. 19 February 2018. Available at:!