Osimertinib is used in several EGFR-mutated NSCLC settings. The exact indication depends on tumor mutation, disease stage, prior treatment and regulatory jurisdiction.
Adjuvant treatment after surgery
In the United States, osimertinib is indicated as adjuvant therapy after tumor resection for adults with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. The U.S. regimen is 80 mg once daily for up to three years, unless recurrence or unacceptable toxicity occurs.
Unresectable stage III disease
FDA approved osimertinib in September 2024 for adults with locally advanced, unresectable stage III EGFR exon 19 deletion or exon 21 L858R NSCLC whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation.
First-line metastatic NSCLC
Osimertinib is indicated as first-line treatment for adults with metastatic NSCLC carrying EGFR exon 19 deletion or exon 21 L858R mutations.
Combination treatment
Osimertinib can also be used with pemetrexed and platinum-based chemotherapy as first-line treatment for eligible adults with locally advanced or metastatic EGFR exon 19 deletion or exon 21 L858R NSCLC. FDA approved this combination in February 2024.
Previously treated T790M-positive disease
The U.S. label also includes treatment of metastatic EGFR T790M-positive NSCLC after progression on or following EGFR TKI therapy.
Regulatory differences
Approved indications vary by jurisdiction. The EMA’s current Tagrisso overview includes adjuvant treatment, unresectable stage III disease following chemoradiation, first-line advanced disease and T790M-positive disease, as well as combination therapy with chemotherapy.