(Alliance News) - FTSE 100-listed drugsmaker AstraZeneca PLC said Friday its key cancer treatment drug Imfinzi has been granted priority review approval by US regulators after positive late-stage clinical trial data.
The US Food & Drug Administration accepted the supplemental biologics license application and granted priority review for Imfinzi - the brand name of durvalumab - for the treatment of extensive-stage small cell lung cancer.
The approval was based on the positive results of the phase three Caspian trial. The trial recently released test results in the Lancet journal which showed "statistically significant and clinically meaningful improvement" in survival rates from the drug.
Imfinzi is already approved for unresectable stage three non-small cell lung cancer in 54 countries after the phase three Pacific trial results.
Shares in Cambridge-based AstraZeneca were 0.6% lower at 7,454.00 pence in London on Friday.
By Ahren Lester; ahrenlester@alliancenews.com
Copyright 2019 Alliance News Limited. All Rights Reserved.
Astrazeneca (AZN)
