Policy & Regulation
The US FDA grants priority review to AstraZeneca's Imfinzi
2 December 2019 -

The US Food and Drug Administration (FDA) has granted priority review to United Kingdom-based AstraZeneca's cancer drug Imfinzi (durvalumab) intended for the treatment of extensive-stage small cell lung cancer (SCLC) in earlier untreated patients, it was reported on Friday.

The company has submitted the drug's supplemental Biologics License Application for its approval in extensive SCLC in treatment-naive patients based on the results from the phase three CASPIAN trial. AstraZeneca has said that results from the phase 3 trial showed an estimated 33.9% of patients survived at 18 months after receiving the investigational treatment compared to 24.7% of patients who were on SoC treatment.

The product's Prescription Drug User Fee Act (PUDFA) date for the SCLC indication has been set for the first quarter of 2020 by the US FDA. The oncology immunotherapy was earlier granted orphan drug designation for the same indication by the US FDA in July 2019.

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