An official website of the United States government
Home
Name
Padcev
Alternate Names
enfortumab vedotin-ejfv
Abbreviations
None
Category
Biologic therapy (BRM, immunotherapy)
Subcategory
antibody and microtubule inhibitor conjugate
NSC Number
None
Primary Site
Bladder
Histology
Urothelial
Remarks
March 30, 2018: FDA has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
12/19/2019 The FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in urothelial cancers. Padcev is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-L1 inhibitor and a platinum-containing chemotherapy. Padcev represents a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.
Feb. 21, 2020 FDA has granted Breakthrough Therapy designation for Padcevtm in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
7/9/2021 The FDA approved Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (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.
December 15, 2023 The FDA approved enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.
12/19/2019 The FDA granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in urothelial cancers. Padcev is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-L1 inhibitor and a platinum-containing chemotherapy. Padcev represents a new type of therapy for patients with advanced urothelial cancer whose disease has progressed on chemotherapy and immunotherapy.
Feb. 21, 2020 FDA has granted Breakthrough Therapy designation for Padcevtm in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.
7/9/2021 The FDA approved Padcev, a Nectin-4-directed antibody and microtubule inhibitor conjugate, for adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand (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.
December 15, 2023 The FDA approved enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC). FDA previously granted accelerated approval to this combination for patients with la/mUC who are ineligible for cisplatin-containing chemotherapy.
Coding
This drug should be coded
