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Pharmaceuticals / Submissions and Approvals

FDA Approves Imfinzi for Stage III Non-small Cell Lung Cancer

Feb. 23, 2018

The FDA approved AstraZeneca’s Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors cannot be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation.

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

The drug targets proteins found on the body’s immune cells and some cancer cells. By blocking the proteins, it may help the body’s immune system attack cancer cells.

The approval for stage III NSCLC was based on a randomized trial of 713 patients whose cancer had not progressed after completing chemotherapy and radiation. The median progression-free survival for patients taking Imfinzi was 16.8 months compared to 5.6 months for those given a placebo.

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