Padcev Approved to Treat Bladder Cancer

December 18, 2019 – The U.S. FDA has granted accelerated approval to PadcevTM (enfortumab vedotin-ejfv), manufactured by Astellas and Seattle Genetics, to treat adult patients who have locally advanced or metastatic urothelial cancer. Patients must have already been treated with a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Padcev is the first in a new class of antibody-drug conjugates that target a cell adhesion molecule called Nectin-4.

Urothelial cancer is the most common type of bladder cancer, accounting for more than 90% of bladder cancer diagnoses. At the locally advanced or metastatic stage, the disease is aggressive with few treatment options available once initial therapy has failed. Padcev works by directly targeting the disease using Nectin-4, which is highly expressed by the cancer’s cells.

In a clinical trial, Padcev delivered an overall response rate of 44%, with 12% of patients having a complete response, meaning there was no detectable evidence of cancer following treatment. Thirty-two percent of patients had a partial response in which tumors shrank or the spread of cancer through the body was reduced from baseline. The median duration of response was 7.6 months.

Recommended dosing is 1.25mg/kg of body weight, up to a maximum dose of 125mg, administered via intravenous (IV) infusion over the course of 30 minutes on Days 1, 8, and 15 of a 28-day cycle. Treatment should continue until disease progression or unacceptable toxicity.

Because the FDA granted accelerated approval to Padcev to fulfill an unmet medical need, further clinical study is required to confirm the drug’s clinical benefit. Failure to confirm clinical benefit may result in a loss of FDA approval. Padcev has launched at a wholesale acquisition cost (WAC) of $2,110 per 20mg vial.