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Padcev
Published
Product name
Padcev
Active ingredient
Enfortumab vedotin
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Padcev (enfortumab vedotin) was approved for the following therapeutic use:
Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand-1 inhibitor.
How this medicine works
Enfortumab vedotin is an antibody-drug conjugate (ADC) targeting Nectin-4, an adhesion protein located on the surface of epithelial cells including urothelial cancer cells. It is comprised of a fully human immunoglobulin G1 (IgG1)-kappa antibody conjugated to the microtubule-disrupting agent, monomethyl auristatin E (MMAE), via a protease-cleavable linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalisation 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 cell death. MMAE released from enfortumab vedotin targeted cells can diffuse into nearby Nectin-4 low-expressing cells resulting in cytotoxic cell death.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Padcev was considered favourable for the therapeutic use approved.