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New FDA Approval for IMFINZI® (durvalumab)

AstraZeneca Pharmaceuticals is pleased to inform you that the US Food and Drug Administration (FDA) has approved IMFINZI® (durvalumab)for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT). 

There have been limited options over the past 10 years in this treatment setting. As of September 2017, the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) recommend durvalumab (IMFINZI) for unresectable Stage III NSCLC in patients whose disease has not progressed following platinum-based CRT.* The prior recommendation following CRT was a period of active surveillance. Up to 89% of these patients will progress to metastatic disease.

IMFINZI is the first and only FDA-approved treatment option in this setting, and we are thrilled to deliver this potentially practice-changing milestone for HCPs, and a critical milestone for patients in need of treatment options. In the Phase III PACIFIC trial, IMFINZI demonstrated an improvement in median progression-free survival (PFS) of 11.2 months compared to placebo (16.8 months for IMFINZI arm vs 5.6 months for placebo arm; hazard ratio 0.52; 95% CI, 0.42-0.65; p<0.0001).

IMFINZI, a human monoclonal antibody directed against PD-L1, is the cornerstone of AstraZeneca’s extensive Immuno-Oncology program across multiple cancer types and stages of disease. In lung cancer, IMFINZI is also being studied for the adjuvant treatment of patients with NSCLC, as well as for the 1st-line treatment of metastatic (Stage IV) NSCLC as monotherapy and in combination with tremelimumab, an investigational anti-CTLA-4 antibody, and chemotherapy. 


To learn more, please visit https://www.imfinzi.com/hcp.html.