Imfinzi Approved to Reduce Risk of NSCLC Progression

AstraZeneca Immunotherapy Imfinzi (durvalumab) is now approved to reduce the risk of progression of non-small cell lung cancer (NSCLC) in patients with stage III disease whose tumor can not be removed surgically after chemotherapy treatment and radiation therapy that stops cancer with spread.

"This is the first approved treatment for NSCLC in Phase III, to reduce the risk of cancer progression, when the cancer has not worsened after chemoradiotherapy," said Richard Pazdur, director of knowledge in oncology at the FDA.

According to Pazdur, while some patients will be cured of the disease after chemotherapy and radiation therapy, the cancer will eventually increase for most patients.

The FDA granted in May 2017 for the first time accelerated Imfinzi approval to treat certain patients with locally advanced or metastatic bladder cancer. The FDA also states that both the priority review that the breakthrough has granted the additional license of biological products (sBLA) AstraZeneca for the new indication.

The FDA said it based the decision to expand the Imfinzi-based label on a randomized study of 713 patients measured progression-free survival (PFS) in patients who had Imfinzi and patients using placebo. In the study, the median PFS for patients using Imfinzi was three times longer than for patients receiving placebo, 16.8 months versus 5.6 months.

With the expanded label, the FDA states that AstraZeneca has accepted a post-marketing commitment (PMC) to provide the organization with the overall survival data of patients who participated in the study.