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TEPOTINIB TAB

Clinical Criteria Summary

Exclusion Criteria

  • CrCl <30 mL/min
  • Prior treatment with another MET inhibitor
  • Severe Hepatic Insufficiency: (Child Pugh C or NCI Organ Dysfunction Working Group classification unless with Gilbert syndrome)
  • Inadequate hematologic function: Hgb <8.5 g/dL or Neutrophils <1.5/mm3 (unless Duffy null phenotype) or Plt <100/mm3
  • 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)
  • Lactating

Inclusion Criteria

  • Patients with metastatic non-small cell lung cancer with a MET exon 14 skipping mutation

Additional 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.

Source Documents