Imfinzi Approved to Reduce Risk of NSCLC Progression
AstraZeneca's immunotherapy Imfinzi (durvalumab) is now approved to reduce the risk of non-small-cell lung cancer (NSCLC) progression in patients with stage III disease whose tumors cannot be surgically removed after treatment with chemotherapy and radiation has caused the cancer to stop spreading.
"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, director of FDA's Oncology Center of Excellence.
According to Pazdur, while some patients will be cured of the disease following chemotherapy and radiation, the cancer will eventually progress for most patients.
FDA first granted accelerated approval to Imfinzi in May 2017 to treat certain patients with locally advanced or metastatic bladder cancer. FDA also says it granted both priority review and breakthrough designation to AstraZeneca's supplemental biologics license (sBLA) for the new indication.
FDA says it based the decision to expand Imfinzi's label based on a randomized study of 713 patients that measured progression free survival (PFS) between patients taking Imfinzi and patients taking a placebo. In the study, the median PFS for patients taking Imfinzi was three times longer than patients who received the placebo, 16.8 months compared to 5.6 months.
With the expanded label, FDA says AstraZeneca has agreed to a postmarketing commitment (PMC) to provide the agency with overall survival data on patients who participated in the study.