ENFORTUMAB VEDOTIN-EJFV INJ
Clinical Criteria Summary
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Exclusion Criteria
- Symptomatic CNS metastases
- Pre-existing sensory or motor neuropathy ≥ Grade 2
- Baseline active keratitis or corneal ulceration
- Moderate or severe hepatic impairment (total bilirubin > 1.5 times the ULN and any AST)
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care 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 discussed and documented
- Patients of child-bearing potential or with partners of child-bearing potential: counseling on contraception and risks vs. benefits provided; effective contraception used during therapy and for 2 months after the last dose
Additional Inclusion Criteria
- Locally advanced or metastatic urothelial carcinoma in patients who had previous PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy
- Locally advanced or metastatic urothelial carcinoma in patients ineligible for platinum-containing chemotherapy and received at least 1 prior line of therapy
Monitoring & Management Requirements
- Monitor blood glucose in all patients prior to each dose and manage hyperglycemia
- Hold dose until blood glucose is < 250mg/dL
- Hyperglycemia and diabetic ketoacidosis occurred in patients with and without pre-existing diabetes mellitus
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Indication & Clinical Setting
- Metastatic urothelial carcinoma
- Cisplatin-ineligible patients
Patient Eligibility Criteria (Cisplatin Ineligibility)
- Creatinine clearance <60 ml/min
- New York Heart Association (NYHA) Class III or higher
- Grade-2 or higher peripheral neuropathy or hearing impairment
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2
Line of Therapy
- First-line therapy in combination with pembrolizumab for cisplatin-ineligible patients
- Single agent enfortumab vedotin remains an option for patients who have progressed on at least one other line of systemic therapy
Formulary & Administrative Requirements
- Recommended for addition to the national formulary with PA-F (Prior Authorization)
- VA Clinical Pathways updated to include enfortumab vedotin plus pembrolizumab as an option for patients determined to be ineligible for cisplatin
Dosing & Administration
- Enfortumab vedotin 1.25 mg/kg (maximum 125mg) IV over 30 minutes on Days 1 & 8 of a 21-day cycle
- Pembrolizumab 200mg IV on day 1 of a 21-day cycle
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Exclusion Criteria
- Symptomatic CNS metastases
- Pre-existing sensory or motor neuropathy ≥ Grade 2
- Baseline active keratitis or corneal ulceration
- Moderate or severe hepatic impairment (total bilirubin > 1.5 times the ULN and any AST)
- Immunosuppression including corticosteroid equivalent to >10 mg per day of prednisone
- Active Autoimmune Disease requiring systemic treatment
- 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
- Locally advanced or metastatic urothelial carcinoma in combination with Pembrolizumab
Pregnancy & Contraception Requirements
- For patients who can become pregnant and patients 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 2 months after stopping treatment
Monitoring & Management Notes
- Monitor blood glucose in all patients prior to each dose and manage hyperglycemia; hold dose of enfortumab vedotin until blood glucose is < 250mg/dL
- Hyperglycemia and diabetic ketoacidosis occurred in patients with and without pre-existing diabetes mellitus.