Padcev FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 31, 2023.
FDA Approved: Yes (First approved December 18, 2019)
Brand name: Padcev
Generic name: enfortumab vedotin-ejfv
Dosage form: Lyophilized Powder for Injection
Company: Astellas Pharma US, Inc.
Treatment for: Urothelial Carcinoma
Padcev (enfortumab vedotin-ejfv) is a Nectin-4 directed antibody-drug conjugate (ADC) for the treatment of urothelial cancer.
- Padcev is indicated:
- in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
- as a single agent for the treatment of adult patients 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 platinum-containing chemotherapy, or
- are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
- Padcev as a single agent is administered via intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
Padcev when used in combination with pembrolizumab is administered as an intravenous infusion over 30 minutes on Days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. - The Padcev product label carries a boxed warning for severe and fatal skin adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
- Warnings and precautions associated with Padcev include hyperglycemia, pneumonitis/interstitial lung disease, peripheral neuropathy, ocular disorders including vision changes, infusion site extravasation, and fetal harm.
- Common adverse reactions when used as a single agent include skin rash, fatigue, peripheral neuropathy, alopecia, decreased appetite, diarrhea, nausea, pruritus, dry eye, dysgeusia, constipation, decreased weight, abdominal pain, and dry skin. Common laboratory abnormalities include increased glucose, increased aspartate aminotransferase, decreased lymphocytes, increased creatinine, decreased albumin, decreased hemoglobin, decreased neutrophils, decreased sodium, increased alanine aminotransferase, decreased phosphate, increased urate, increased lipase, and decreased platelets.
Additional adverse reactions when used in combination with pembrolizumab include urinary tract infection, increased potassium, and decreased platelets.
Development timeline for Padcev
Further information
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