IndicationsOsimertinib is a kinase inhibitor indicated for:
- Adjuvant treatment after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
- First-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
- Treatment of adult patients with metastatic NSCLC whose tumors are EGFR T790M mutation-positive, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.
Dosage and Administration
- Adjuvant treatment of early-stage NSCLC:
80 mg taken orally once daily, with or without food, until disease recurrence, unacceptable toxicity, or for up to 3 years. - Metastatic NSCLC:
80 mg taken orally once daily, with or without food, until disease progression or unacceptable toxicity.
Specification
80 mg per tablet, 30 tablets per box.
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