Padcev Snags FDA Priority Reviews for Urothelial Cancer Indication

The FDA has granted priority reviews for two supplemental Biologics License Applications (sBLAs) by Seagen and Astellas Pharma for Padcev, their antibody-drug conjugate therapy for treating bladder cancer.

A targeted therapy designed to kill tumor cells while sparing healthy cells, Padcev (enfortumab vedotin-ejfv) is currently only approved for use in the U.S. for treating locally advanced or metastatic urothelial cancer in patients previously treated with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy both before and after surgery.

One sBLA seeks to change Padcev’s accelerated approval granted by the FDA in 2019 to a full approval, while the second seeks to expand the drug’s indication to include urothelial cancer patients previously treated with a PD-1 or PD-L1 inhibitor who aren’t eligible for treatment with cisplatin.

The FDA has granted the supplemental applications priority as part of its Real-Time Oncology Review pilot program and has set a target decision date of Aug. 17.