PADCEV (enfortumab vendotin-ejfv)

OFFICE ADMINISTRATION – IV infusion

Indications for Prior Authorization:
  • Indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
Patient must meet the following criteria for the indication(s) above:
  • Patient is 18 years old or older, AND
  • Prescribed by or in consultation with an oncologist, AND
  • Diagnosis of locally advanced or metastatic urothelial cancer (mUC), AND
  • Patient has received prior treatment with a platinum-based chemotherapy (e.g., carboplatin, cisplatin) in the neoadjuvant/adjuvant, locally advanced or metastatic setting, AND
  • Patient has received prior treatment with one immune checkpoint inhibitor (CPI) in the neoadjuvant/adjuvant, locally advanced or metastatic setting unless contraindicated
    • Programmed death receptor-1 (PD-1) inhibitor (e.g., Opdivo® (nivolumab), Keytruda® (pembrolizumab)), OR
    • Programmed death-ligand 1 (PD-L1) inhibitor (e.g., Tecentriq® (atezolizumab), Imfinzi™ (durvalumab), Bavencio® (avelumab))
  • Avoid use of Padcev™ in patients with moderate or severe hepatic impairment.

Dosing:
  • 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity
  • Dose modified for adverse reactions
Approval:
  • 1 year

 

Last review date: May 19, 2020

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