ERDAFITINIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Serum phosphate above the upper limit of normal
- Symptomatic CNS metastases
- Any corneal or retinal abnormality identified by ophthalmologic exam
- Unmanageable CYP2C9 or CYP3A4 drug interaction
- Unmanageable CYP3A4, OAT2, or P-glycoprotein substrate drug interaction
- 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
- Baseline ophthalmologic exam, including Optical Coherence Tomograph (OCT) where available
- 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 1 month after the last dose
- Known Poor Metabolizer genotype (CYP2C93/3): monitor for increased risk of adverse events
Indication & Prior Therapy Requirements
- Locally advanced (unresectable) or metastatic urothelial carcinoma
- FGFR3 alteration based on companion diagnostic or next generation sequencing
- Progressed during or following at least 1 prior line of systemic therapy
- Not recommended if patient is eligible for or has not received prior PD-1 or PD-L1 inhibitor therapy