Jun. 23 at 8:05 PM
$AZ AstraZeneca reports Datroway approved in U.S. for EGFR-mutated NSCLC
Datroway has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy, AstraZeneca announced. "This indication is approved under accelerated approval based on objective response rate and duration of response.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. 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 stated.
