FDA approval date:
PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate
indicated for the treatment of adult patients with locally advanced or
metastatic urothelial cancer who have previously received a programmed
death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and
a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally
advanced or metastatic setting.
Mechanism of Action:
Enfortumab vedotin-ejfv is an ADC. The antibody is a human IgG1 directed against Nectin-4, an adhesion
protein located on the surface of cells. The small molecule, MMAE, is a microtubule-disrupting agent, attached
to the antibody via a protease-cleavable linker. Nonclinical data suggest that the anticancer activity of
enfortumab vedotin-ejfv is due to the binding of the ADC to Nectin-4-expressing cells, followed by
internalization of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. Release of
MMAE disrupts the microtubule network within the cell, subsequently inducing cell cycle arrest and apoptotic
For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a lyophilized
powder in a single-dose vial for reconstitution.
The most common adverse reactions (≥20%) included fatigue, peripheral
neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea,
dry eye, pruritus and dry skin.