The U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the investigational agent enfortumab vedotin, also known as ASG-22CE, and granted Priority Review for the treatment of patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. 
Urothelial cancer is the most common type of bladder cancer (90% of all cases). In 2018, more than 82,000 people were diagnosed with bladder cancer in the United States Globally, approximately 549,000 people were diagnosed with bladder cancer last year, and there were approximately 200,000 deaths worldwide.
The filing is based on results from the first cohort of patients in the single-arm EV-201 pivotal phase II clinical trial presented as a late-breaking oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) held in Chicago, Ill, in early June 2019.
In the this trial, which includes 2 cohorts, the primary endpoint is confirmed objective response rate per blinded independent central review. Secondary endpoints include assessments of duration of response, disease control rate, progression-free survival, overall survival, safety and tolerability.
The first cohort includes patients those who have also been treated with a platinum-containing chemotherapy and those who have not received a platinum-containing chemotherapy. This part of the trial enrolled 128 patients at multiple centers internationally. The second cohort includes patients who are ineligible for cisplatin. This part of the trial continues to enroll patients.
Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of March 15, 2020.
Enfortumab vedotin is a novel investigational antibody-drug conjugate (ADC) that targets Nectin-4, a protein that is highly expressed in urothelial cancers and other solid tumors, has been identified as a target for antibody-drug conjugates by Astellas.
The FDA granted enfortumab vedotin Breakthrough Therapy designation in March 2018, for patients with locally advanced or metastatic urothelial cancer whose disease has progressed during or following checkpoint inhibitor therapy.
“The FDA’s filing of the application for enfortumab vedotin and granting of Priority Review is a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need,” noted Roger Dansey, MD., Chief Medical Officer at Seattle Genetics.
“If approved, enfortumab vedotin will likely play an important role in the treatment of advanced urothelial cancer, and we look forward to working with the FDA as the review process advances,” said Andrew Krivoshik, M.D., PhD., Senior Vice President and Oncology Therapeutic Area Head at Astellas.
Astellas and Seattle Genetics are co-developing enfortumab vedotin under a collaboration that was entered into in 2007 and expanded in 2009. Under the collaboration, the companies are sharing costs and profits on a 50:50 basis worldwide.
A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4 – NCT02091999
A Study of Enfortumab Vedotin for Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer (EV-201) – NCT03219333
 A Study of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects With Metastatic Urothelial Cancer and Other Malignant Solid Tumors That Express Nectin-4. Online. Bladder Cancer (BCAN). Last accessed September 15, 2019
 American Society of Clinical Oncology. Bladder Cancer: Statistics (05-2019). Online
 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018;68(6):394-424.