FDA Approves Padcev (Enfortumab vedotin-ejfv) for Bladder Cancer

The US Food and Drug Administration (FDA) has approved a new type of drug for certain people with bladder cancer. Padcev (enfortumab vedotin-ejfv) can treat people with advanced urothelial carcinoma, the most common type of bladder cancer, if it got worse after standard chemotherapy and immunotherapy treatments.

Padcev is a combination of 2 different types of drugs, called an antibody-drug conjugate. The antibody part acts like a homing signal, bringing the chemo drug, monomethyl auristantin E, directly to bladder cancer cells with a protein called Nectin-4 on them and killing them.

The FDA based its approval of this drug on a clinical trial of 125 people with advanced urothelial carcinoma who had already been treated with platinum chemotherapy (such as cisplatin) and immunotherapy (specifically, a PD-1 or PD-L1 inhibitor). Twelve percent of people had a complete response, meaning their tumors were no longer detectable, and 32% had a partial response, meaning their tumors got smaller but didn’t disappear. The average amount of time the improvements lasted was 7.6 months. Patients get Padcev intravenously (through the vein, or IV) once a week for 3 weeks with 1 week off.

The FDA granted Padcev accelerated approval, priority review, and breakthrough therapy designations – programs designed to speed up the availability of drugs to treat serious diseases. Another clinical trial will be required to confirm the results.

The most common side effects were fatigue, peripheral neuropathy (a type of nerve damage), nausea, taste changes, decreased appetite, diarrhea, rash, hair loss, dry eye, dry skin, itching, and high blood sugar levels. Patients of reproductive age should use birth control while taking Padcev. Women who are pregnant or breastfeeding should not take it.

Padcev is marketed by Astellas Pharma US Inc.