ENTRECTINIB CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Prior history of prolonged QTc interval (repeated QTc interval >450 msec) or risk factors for torsade de pointes
- Gastrointestinal condition that may interfere with entrectinib absorption
- Interstitial lung disease, interstitial fibrosis, or tyrosine kinase inhibitor-induced pneumonitis
- Prior ROS1 or NTRK tyrosine kinase inhibitor therapy
- Unmanageable drug interaction identified
- Creatinine clearance <30 mL/min
- Total bilirubin >1.5 times the ULN (unless with Gilbert’s syndrome)
- 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 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
- Female patients of child-bearing potential or male patients with female partner of child-bearing potential: counseling provided on contraception and risks vs. benefits of treatment; use effective contraception during therapy and for at least 5 weeks (female patients) or 3 months (males and female partners) after the final dose
- Additional Inclusion Criteria (At least one must be met)
- Patient with metastatic non-small cell lung cancer whose tumor is ROS1-positive
- Patient with solid tumor that is metastatic or unresectable AND:
- Has a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation AND
- Has progressed following treatment or has no satisfactory alternative therapy