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Two sBLAs Accepted by FDA for Enfortumab Vedotin-ejfv in Urothelial Cancer

By: JNCCN 360 Staff
Posted: Tuesday, April 20, 2021

On April 19, Seagen and Astellas Pharma announced that the U.S. Food and Drug Administration (FDA) filed two supplemental biologics license application (sBLAs) submissions for enfortumab vedotin-ejfv (Padcev) for review as part of the Real-Time Oncology Review pilot program. The applications were granted Priority Review, with a target action date of August 17, 2021. In 2019, this antibody-drug conjugate received accelerated approval in the United States for the treatment of adults with locally advanced or metastatic urothelial cancer who were previously treated with a PD-L1 inhibitor and platinum-containing chemotherapy before or after surgery.

The first application is based on the phase III EV-301 trial in the setting of locally advanced or metastatic urothelial cancer. Enfortumab vedotin was compared with physician’s choice of chemotherapy (docetaxel, paclitaxel, or vinflunine) in about 600 patients who were previously treated with a PD-1/PD-L1 inhibitor and a platinum-based therapy. The second application, based on the EV-201 trial cohort 2, is requesting an expansion of the current indication to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/PD-L1 inhibitor and are ineligible for cisplatin.



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