AstraZeneca gets FDA approval, stops kidney drug trial after 'overwhelming efficacy'
By Iain Gilbert
Date: Monday 30 Mar 2020
(Sharecast News) - Biopharmaceutical giant AstraZeneca said on Monday that two of its top-selling drugs had shown advances in the treatment of deadly diseases.
Imfinzi, AstraZeneca's cancer drug, was approved by the US Food and Drug Administration for use as a first-line treatment for adult patients with extensive-stage small-cell lung cancer.
The FDA's approval was based on positive results from AZN's phase III CASPIAN trial, which showed Imfinzi demonstrated a "statistically significant and clinically meaningful improvement" in overall survival when used in combination with standard-of-care chemotherapies.
However, the FTSE 100 company noted that the second experimental arm, which saw it test tremelimumab with Imfinzi and standard-of-care chemotherapies together, did not meet its primary endpoint.
AZN's vice president of oncology Dave Frederickson said: "The US approval of Imfinzi brings a new medicine to extensive-stage small cell lung cancer patients in urgent need of new options.
"Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease."
AstraZeneca also said that its diabetes drug Farxiga demonstrated "overwhelming efficacy" in its phase III trial, leading the group to stop the trial early following a recommendation from an independent data monitoring committee.
As of 0825 BST, AstraZeneca shares were up 0.66% at 6,850p.
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