Padcev FDA Approval History
Last updated by Judith Stewart, BPharm on July 15, 2021.
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 patients with locally advanced or metastatic urothelial cancer.
- Padcev is indicated for use in patients who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
- Padcev 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.
- 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). Padcev can cause serious adverse reactions including hyperglycemia, pneumonitis, peripheral neuropathy, ocular disorders including vision changes, infusion site reactions, and fetal harm.
- Common adverse reactions include, skin rash, changes in liver and kidney function tests, increased blood glucose, fatigue, peripheral neuropathy, decreased white blood cell, red blood cell, and platelet counts, alopecia, decreased appetite, diarrhea, decreased sodium, phosphate and protein (albumin) in the blood, nausea, pruritus, change in sense of taste, increased uric acid in the blood, anemia, increased lipase, decreased weight, and dry skin.
Development Timeline for Padcev
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