Osimertinib is a biomarker-directed treatment used in specific forms and stages of non-small cell lung cancer (NSCLC).
The exact approved indications differ by regulatory jurisdiction. The U.S. FDA currently recognizes several osimertinib treatment settings, while the EMA has its own authorization wording.
Adjuvant treatment after surgery
Osimertinib is approved in the United States as adjuvant therapy after tumor resection for adults with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
The objective of adjuvant therapy is to reduce the risk of recurrence after apparently complete surgical removal.
Locally advanced unresectable stage III disease
The U.S. FDA added an indication for adults with locally advanced, unresectable stage III EGFR exon 19 deletion or L858R NSCLC whose disease has not progressed during or following platinum-based chemoradiation.
First-line advanced or metastatic disease
Osimertinib is used as first-line targeted therapy for adults with advanced or metastatic NSCLC carrying specified EGFR alterations, particularly exon 19 deletions and exon 21 L858R in U.S. labeling.
Combination with chemotherapy
The U.S. indication also includes osimertinib in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for adults with locally advanced or metastatic EGFR exon 19 deletion or L858R NSCLC.
Previously treated T790M-positive disease
Osimertinib was originally developed in the context of acquired EGFR T790M resistance. U.S. labeling includes treatment of metastatic EGFR T790M-positive NSCLC that has progressed on or after EGFR TKI therapy, when detected by an FDA-approved test.
Biomarker testing
Treatment selection should be based on appropriate molecular testing. FDA companion diagnostic information identifies EGFR exon 19 deletions, L858R and T790M in relation to osimertinib.
Not every use is universal
A treatment approved in one jurisdiction may not have the same label in another. Off-label or investigational uses should not be presented as approved indications.
Clinical decision-making
Oncologists consider:
- EGFR mutation status
- Disease stage
- Previous treatment
- Surgical history
- Chemoradiation history
- Presence of CNS disease
- Overall clinical condition
- Drug interactions
- Potential toxicity
- Applicable regulatory labeling