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.
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