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WASHINGTON -- The as the first adjuvant therapy for EGFR-mutant non-small cell lung cancer (NSCLC).

The approval pertains to early-stage NSCLC associated with exon 19 deletions or exon 21 L858R mutations. The drug initially received FDA approval for pretreated metastatic EGFR-positive NSCLC, followed by approval as for metastatic EGFR-positive disease.

"[The] 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, MD, of the FDA's Center for Drug Evaluation and Research, in a statement. "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."

Support for the approval came from the phase III randomized placebo-controlled ADAURA trial that showed an 80% lower risk of disease recurrence or death among patients who received osimertinib following surgery. The trial included 682 patients with operable early-stage NSCLC associated with EGFR exon 19 deletions or exon 21 L858R mutations. Following complete surgical resection and standard chemotherapy, patients received osimertinib or placebo.

The primary endpoint of ADAURA was disease-free survival (DFS) among patients with stage II and IIIA disease. The addition of osimertinib to chemotherapy resulted in a hazard ratio (HR) of 0.17 for the risk of disease recurrence or death (95% CI 0.12-0.23, P<0.0001). In the overall study population of patients with stage IB-IIIA disease, treatment with osimertinib was associated with an HR of 0.20 versus placebo (95% CI 0.15-0.27, P<0.0001). The 2-year DFS rate was 89% in the osimertinib arm versus 52% in the placebo group.

During the ADAURA trial, the safety profile of osimertinib remained consistent with results of prior studies and experience in clinical practice. The most common side effects of osimertinib include diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation around the nails, sore mouth, fatigue, and cough.

ADAURA principal investigator Roy Herbst, MD, PhD, of the Yale Cancer Center in New Haven, Connecticut, cited the implications of the trial results and FDA approval for precision medicine strategies in the treatment of lung cancer.

"Adjuvant Tagrisso has demonstrated an unprecedented disease-free survival benefit for early-stage lung cancer patients with EGFR mutations who face high rates of recurrence even after successful surgery and subsequent chemotherapy," Herbst said from drug developer AstraZeneca. "This approval reinforces how critical it is to test all lung cancer patients for EGFR mutations before deciding how to treat them and regardless of their stage at diagnosis. This will help ensure as many patients as possible can benefit from this potentially practice-changing treatment."

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