AstraZeneca Imfinzi treatment gets FDA priority review

(Sharecast News) - AstraZeneca said the US Food and Drug Administration had accepted a supplemental Biologics License Application (sBLA) and granted priority review for its Imfinzi treatment of patients with previously untreated extensive-stage small cell lung cancer.
The sBLA was based on positive results from a phase III CASPIAN trial published in The Lancet, showing Imfinzi in combination with standard-of-care (SoC) chemotherapy demonstrated a "statistically significant and clinically meaningful" improvement in overall survival vs SoC, the company said on Friday.

The risk of death was reduced by 27%, with median overall survival of 13 months for Imfinzi plus chemotherapy vs. 10.3 months for SoC. Results showed an estimated 33.9% of patients were alive at 18 months following treatment with Imfinzi plus chemotherapy vs. 24.7% of patients receiving SoC.