TEPOTINIB TAB
Clinical Criteria Summary
Exclusion Criteria
- CrCl <30 mL/min
- Prior treatment with another MET inhibitor
- Moderate or Severe Hepatic Insufficiency: AST/ALT > 3 × ULN or total bilirubin > 1.5 × ULN. For patients with liver metastases: AST/ALT > 5 × ULN or total bilirubin > 1.5 × ULN.
- Inadequate hematologic function with one of the following: Hgb <8.5 g/dL or Neutrophils <1.5 x 109/L or Plt <100 x 109/L
- Presence of ALK mutation or sensitive EGFR mutation (exon 19 del or exon 21 alteration)
- NYHA heart failure Class III or IV
- Untreated brain metastases
- Pregnancy (i.e. known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care is provided by a VA/VA Community Care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
- Patients of child-bearing potential and patients with partners of child-bearing potential: counseling provided on contraception and risks vs. benefits of treatment. Use effective contraception during therapy and for one week after the last dose.
Additional Inclusion Criteria
- Patients with metastatic non-small cell lung cancer with a MET exon 14 skipping mutation