The U.S. Food and Drug Administration has approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.

“Today’s approval of Tagrisso demonstrates how additional research on therapies approved in later stages of cancer can eventually improve treatment options for patients in earlier stages,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “With this approval, patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer.”

Lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide. In the U.S., approximately 229,000 adults will be diagnosed with lung cancer in 2020, of which 76% of cases will be non-small cell lung cancer. Approximately 20% of patients with non-small cell lung cancer will have epidermal growth factor receptor (EGFR) mutations, which are mutations on a protein that causes rapid cell growth, and consequently, helps cancer spread. Although most patients who are diagnosed with non-small cell lung cancer have unremovable tumors, 30% have resectable disease; thus, more than 10,000 patients nationwide each year may be candidates for Tagrisso as adjuvant therapy after tumor removal. Tagrisso was approved in 2018 for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.