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The FDA approved durvalumab for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are unresectable and whose cancer has not progressed after treatment with chemoradiation.

FDA; non-small cell ... - Click to enlarge in new windowFDA; non-small cell lung cancer. FDA; non-small cell lung cancer

"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 PD-1/PD-L1 pathway. By blocking these interactions, it may help the body's immune system attack cancer cells. The treatment 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 a randomized 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 durvalumab or a placebo. 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 overall survival with durvalumab after chemotherapy and radiation.


"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," noted Scott J. Antonia, MD, PhD, Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Fla., and investigator in the PACIFIC trial. "Given that up to 89 percent 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 [this] approval of [durvalumab] will change how we treat these patients."


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


Serious risks include immune-mediated side effects, such as pneumonitis, hepatitis, colitis, endocrinopathies, and nephritis. Other serious side effects 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.