The U.S. Food and Drug Administration approved Bothell, Wash.-based Seattle Genetics Inc.'s and Tokyo-based Astellas Pharma Inc.'s Padcev to treat certain urothelial cancer patients.
Padcev, or enfortumab vedotin-ejfv, is indicated to treat adult patients with locally advanced or spreading urothelial cancer who have not responded to a PD-1/L1 inhibitor — a cancer therapy that targets the immune system — and platinum-containing chemotherapy.
Urothelial cancer, accounting for more than 90% of bladder cancer cases, begins in the urothelial cells that line the urethra, bladder, ureters, renal pelvis and other nearby organs.
The regulator granted accelerated approval to Padcev based on data from a phase-2 single-arm study which showed tumor shrinkage in 44% of 125 patients, while 12% of patients had no signs of cancer after treatment.
Padcev received approval about three months before the expected decision date of March 15, 2020.
The FDA's accelerated approval is a conditional approval for drugs used to treat serious diseases with an unmet need. A further clinical trial is required by the regulator to confirm the drug's benefit to patients.
Padcev, which previously received a breakthrough therapy designation and a priority review designation from the FDA, targets a protein called Nectin-4 that is found in 97% of urothelial cancers. The drug is an antibody-drug conjugate, a type of drug that specifically targets cancer cells.