The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) by Astellas Pharma for patients with locally advanced or metastatic urothelial cancer whose disease has progressed on platinum-based chemotherapy and immunotherapy. The drug targets the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers, such as bladder cancers.

“Antibody-drug conjugates are strategic tools in the targeted treatment of cancer. These conjugates combine the ability of monoclonal antibodies to target specific receptors on cancer cells and then deliver a drug to the cancer cell,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, stated in an FDA news release. “Padcev is an antibody-drug conjugate that targets Nectin-4, a cell surface protein expressed on bladder cancer cells and a cell-killing agent, monomethyl auristantin E.”

In the phase 2 EV-201 clinical trial of 125 patients with locally advanced or metastatic urothelial cancer previously treated with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy, enfortumab vedotin-ejfv treatment resulted in a 12% complete response rate and a 32% partial response rate that lasted a median 7.6 months.

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The recommended dose of enfortumab vedotin-ejfv is 1.25 mg/kg (up to a maximum dose of 125 mg) given as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

The most common drug side effects include fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritus, and dry skin. Blood sugar levels should be monitored closely to avoid diabetic ketoacidosis. If new or worsening peripheral neuropathy occurs, enfortumab vedotin-ejfv should be reduced or discontinued. The drug may produce dry eyes and vision changes, so consider artificial tears and ophthalmology referral. Infusion site extravasation may occur. Women who are pregnant or breastfeeding should not take the medication.

According to Astellas, a global, randomized phase 3 confirmatory clinical trial (EV-301) of enfortumab vedotin-ejfv is underway.

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FDA approves new type of therapy to treat advanced urothelial cancer. FDA; December 18, 2019. Accessed at

FDA grants accelerated approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for people with locally advanced or metastatic urothelial cancer, the most common type of bladder cancer. Astellas; December 19, 2019. Accessed at

PADCEV (enfortumab vedotin-ejfv) for injection, for intravenous use Initial US Approval: 2019. Accessed on December 19, 2019 at Prescribing information accessible here ​