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FDA approves Imfinzi for unresectable stage III NSCLC tumors
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The FDA has approved durvalumab for treatment of patients with stage III non-small cell lung cancer with unresectable tumors and whose cancer has not progressed after treatment with chemoradiation, according to an FDA press announcement.
The approval of durvalumab (Imfinzi, AstraZeneca), a PD-L1 inhibitor, was based on the results of a randomized trial of 713 patients. Researchers evaluated the length of time the tumors did not have significant growth and found patients receiving durvalumab experienced a median progression-free survival of 16.8 months. Patients receiving a placebo experienced a median progression-free survival of 5.6 months, according to the FDA release.
In July 2017, the FDA granted breakthrough therapy designation to durvalumab for treatment of locally advanced, unresectable NSCLC.
The FDA granted accelerated approval of the treatment in 2017 for certain patients with locally advanced or metastatic bladder cancer, according to the release.