AstraZeneca's lung cancer therapy Tagrisso approved in China

AstraZeneca announced Monday that the China Food and Drug Administration (CFDA) approved Tagrisso (osimertinib) for the treatment of adults with locally-advanced or metastatic EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC) whose disease has progressed on or after EGFR tyrosine kinase inhibitor therapy. The company noted that the oral drug is its first medicine cleared under the CFDA's priority review pathway.

Sean Bohen, chief medical officer at AstraZeneca, suggested that approval in China represents a "significant opportunity" for Tagrisso, adding that the country's "EGFR mutation rates are some of the highest in the world." According to the drugmaker, approximately 30 percent to 40 percent of Asian patients with NSCLC have the EGFR mutation at diagnosis, and nearly two thirds of these patients whose disease progresses after treatment with an EGFR tyrosine kinase inhibitor develop the T790M mutation.