PEMIGATINIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Care not provided by a VA or VA Community Care provider of hematology/oncology services
- Unmanageable CYP3A inhibitor/inducer drug interaction identified
- Clinically significant corneal or retinal disorder identified by ophthalmologic exam
- Serum phosphate level greater than ULN
- Untreated, clinically unstable brain and/or CNS metastases
- Pregnancy (i.e. known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Diagnosis of advanced/metastatic or surgically unresectable cholangiocarcinoma
- Documented disease progression after at least one prior systemic therapy
- Confirmed tumor expression of FGFR2 fusion or select rearrangement by FDA-approved next generation sequencing
- Baseline ophthalmology exam, including optical coherence tomography (OCT), performed
- Goals of care and role of Palliative Care consult have been discussed and documented
- ECOG Performance Status 0-2