Monograph

MAFOsimertinib Tablet 40 mg, 80 mg

Treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy. For patients with isolated brain metastases who are clinically ineligible for re-biopsy and where T790M cannot be confirmed, osimertinib may be used until progression.

MSHLOsimertinib Tablet 40 mg, 80 mg

1) For newly diagnosed locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer, including patients who have developed intolerance to another EGFR tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal.
2) Treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy. For patients with isolated brain metastases who are clinically ineligible for re-biopsy and where T790M cannot be confirmed, osimertinib may be used until progression.
3) Adjuvant treatment after tumour resection in patients with stage IB to IIIA non-small-cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Treatment should be continued until disease recurrence or unacceptable toxicity or for a maximum of 3 years.