FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

AstraZeneca’s Imfinzi Grabs Orphan Drug Status for Small Cell Lung Cancer

July 30, 2019
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The FDA has granted AstraZeneca’s Imfinzi (durvalumab) orphan drug designation for treating small cell lung cancer (SCLC).

The drug is currently approved in more than 45 countries, including the US, EU and Japan, for unresectable, Stage III NSCLC after chemotherapy and radiation therapy. The company recently reported that Imfinzi met its endpoints in a phase 3 trial with positive overall survival results.

SCLC makes up around 15 percent of all cancer diagnoses and is the most aggressive form of lung cancer, with only six percent of patients surviving after five years.

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