PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate indicated….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.

Astellas Pharma Inc...and Seagen Inc. (Nasdaq:SGEN) today announced that the European Commission (EC) has approved PADCEV™ (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The EC approval is supported by data from the global phase 3 EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.

Astellas Pharma Inc...and Seagen Inc...today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV® (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy...“The MHLW’s review of enfortumab vedotin in just six months, supported by overall survival data from a pivotal Phase 3 clinical trial, reflects the seriousness of this condition and the potential benefit of enfortumab vedotin for patients in Japan.”

After median follow-up of approximately 2 years, enfortumab vedotin maintained clinically meaningful overall survival benefit versus chemotherapy, consistent with findings from the EV-301 primary analysis; PFS and overall response benefit remained consistent.

In EV-301 (NCT03474107), patients with locally advanced or metastatic urothelial carcinoma (la/mUC)…median OS was significantly prolonged by 3.97 months with EV compared with chemotherapy (median OS: 12.91 vs 8.94 months, respectively; HR = 0.704 [95% CI: 0.581-0.852], 1-sided P= 0.00015). Additionally, the OS benefit of EV was retained in the majority of prespecified subgroups. PFS also was improved with EV (median 5.55 months) vs chemotherapy (median 3.71 months) (HR = 0.632 [95% CI: 0.525-0.762]; 1-sided P< 0.00001). EV continues to show significant and consistent survival advantage over standard chemotherapy in patients with treatment-experienced la/mUC.

Astellas Pharma Inc....and Seagen Inc. (Nasdaq:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of the antibody-drug conjugate (ADC) PADCEV™ (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer....The CHMP recommendation is based on data from the global phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

Astellas Pharma Inc...today announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s New Drug Application (NDA), which was submitted in March. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in Japan for the treatment of patients with locally advanced or metastatic urothelial cancer...The NDA includes data from the phase 3 EV-301 trial and the phase 2 EV-201 trial, both global clinical trials with investigational sites in Japan.

EV is the first therapy to show significant survival advantage over standard chemotherapy in patients with treatment-experienced la/mUC.

Enfortumab vedotin significantly prolonged survival as compared with standard chemotherapy in patients with locally advanced or metastatic urothelial carcinoma...Overall survival was longer in the enfortumab vedotin group than in the chemotherapy group (median overall survival, 12.88 vs. 8.97 months; hazard ratio for death, 0.70; 95% confidence interval [CI], 0.56 to 0.89; P=0.001).

Seattle Genetics, Inc. and Astellas Pharma Inc...today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer...

Astellas Pharma Inc. and Seattle Genetics, Inc. (NASDAQ: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).