LAROTRECTINIB CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Malabsorption syndrome or other condition affecting oral absorption
- Unmanageable drug interaction
- Known pregnancy
- Lactating
Inclusion Criteria
- Patient has a metastatic solid tumor that is unresectable with an NTRK gene fusion without a known acquired resistance mutation (G595R, G623R, G696A, and F617L)
- Patient has progression on standard treatment(s) or no standard alternative treatment exists
- Baseline hepatic function (AST, ALT, Tbili) evaluated for larotrectinib dose adjustment
Additional Inclusion Criteria
- Care is provided by a VA/VA Community Care oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Additional Inclusion Criteria, if applicable
- For female patients who can become pregnant: Pregnancy must be excluded prior to receiving Larotrectinib.
- For females who can become pregnant and males with partners who can become pregnant: Counseling provided on potential risks vs. benefits of treatment and the use of effective contraception during therapy and for at least 1 week after the final dose.