Enfortumab Vedotin Plus Pembrolizumab Shows Promise in Urothelial Cancer

Published: Saturday, Sep 28, 2019

TRAEs of special interest for enfortumab vedotin (peripheral neuropathy, rash, and non-fasting hyperglycemia) occurred at rates similar to those observed in studies of single-agent enfortumab vedotin. Immune-mediated adverse events requiring systemic steroids affected 9 patients and were grade ≥3 severity in 5 cases.

Earlier this month, the FDA granted a priority review designation to a biologics license application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. Under the Prescription Drug User Fee Act, the FDA will make a decision on the BLA by March 15, 2020.

Hoimes C, Rosenberg J, Srinivas S, et al. EV-103: Initial results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma. Presented at: 2019 ESMO Congress; Barcelona, Spain; September 27 to October 1, 2019. Abstract 901O.
<<< View more from the 2019 ESMO Congress

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Publication Bottom Border
Border Publication