AstraZeneca's Datroway gets green light from FDA

(Sharecast News) - Drugmaker AstraZeneca's Datroway has been approved in the US for adult patients with previously treated advanced EGFR-mutated non-small cell lung cancer. AstraZeneca said the indication was approved under accelerated approval based on objective response rate and duration of response. However, it said continued approval may be contingent upon verification and description of clinical benefits in a confirmatory trial.

The FTSE 100-listed firm noted that the approval follows Priority Review and Breakthrough Therapy Designation by the Food and Drug Administration based on results from a subgroup analysis of the TROPION-Lung05 Phase II trial and supported by data from the TROPION-Lung01 Phase III trial.

AstraZeneca also pointed out that Datroway was the "first and only" TROP2-directed therapy approved for the treatment of lung cancer in the US.

Dave Fredrickson, executive vice president of AstraZeneca's oncology haematology business unit, said: "This first approval of Datroway in lung cancer provides a much-needed option to patients with advanced EGFR-mutated lung cancer whose disease has become resistant to past treatments, regardless of the driving mutation.

"We have long supported patients with EGFR-mutated lung cancer and are proud to bring another innovative treatment option to this community."

Reporting by Iain Gilbert at Sharecast.com