AstraZeneca Wins FDA Priority Review for Lung Cancer Drug
AstraZeneca has received a Priority Review designation from the FDA for Tagrisso (osimertinib) as an adjunct treatment for patients with early-stage, epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The Priority Review status for the company’s supplemental New Drug Application was supported by data from a phase 3 study demonstrating Tagrisso significantly increased disease-free survival.
Tagrisso was granted Breakthrough Therapy designation by the FDA in July. The drug is already approved as a first-line treatment for patients with the disease in the U.S., EU, Japan and China, among other countries.