FDA Expands Approval of Durvalumab in Advanced Unresectable Lung Cancer
On February 16, 2018, the U.S Food and Drug Administration (FDA) approved durvalumab (Imfinzi) 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. Durvalumab is an immunotherapy drug that targets the PD-1/PD-L1 pathways and was previously granted accelerated approval in 2017 for the treatment of certain patients with locally advanced or metastatic bladder cancer.
This current approval was based on the randomized PACIFIC trial of 713 patients whose cancer had not progressed after chemoradiation. The trial examined the length of time until progression-free survival. The median progression-free survival for patients receiving durvalumab was 16.8 months compared with 5.6 months for patients receiving a placebo. The most common adverse events associated with durvalumab include cough, fatigue, pneumonitis, upper respiratory tract infections, dyspnea, and rash.