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Device/Product name
Active Ingredient
Enfortumab vedotin
Date of decision
Submission type
New biological entity
ATC codes
What was the decision based on
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.
What steps were involved in the decision process

Registration timeline

This evaluation was facilitated through Project Orbis, an initiative of the United States (US) Food and Drug Administration (FDA) Oncology Center of Excellence (OCE). Under this project, the FDA and the TGA collaboratively reviewed the application. This innovative evaluation process provided a framework for process alignment and management of evaluation issues in real-time across jurisdictions.

Each regulator agency maintained its regulatory process to make independent decisions about the approval (market authorisation).

Description Date
Submission dossier accepted and first round evaluation commenced 1 April 2021
First round evaluation completed 31 August 2021
Sponsor provides responses on questions raised in first round evaluation 30 September 2021
Second round evaluation completed 22 June 2022
Delegate's overall benefit-risk assessment and request for Advisory Committee advice 5 January 2022
Sponsor's pre-Advisory Committee response 17 January 2022
Advisory Committee meeting 3 and 4 February 2022
Registration decision (Outcome) 30 June 2022
Completion of administrative activities and registration on ARTG 7 July 2022
Number of working days from submission dossier acceptance to registration decision* 240

*Statutory timeframe for standard applications is 255 working days

Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia
Dose forms
Powder for injection
20 mg and 30 mg (10 mg/mL after reconstitution)
Other ingredients

Histidine, histidine hydrochloride monohydrate, trehalose dihydrate, and polysorbate 20

Pack sizes
Routes of administration
Intravenous infusion

The recommended dose of Padcev is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥ 100 kg) administered as an intravenous infusion over 30 minutes on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.

For further information refer to the Product Information.

Pregnancy category

Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved

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.

What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
  • Padcev (enfortumab) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Padcev must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
  • The Padcev European Union (EU)-risk management plan (RMP) (version 1.0, dated March 2022; data lock point 15 September 2020), with Australia specific annex (version 5.0, dated 13 June 2022), included with Submission PM-2021-00635-1-4, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.

    An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).

    Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.

    The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.

  • For all injectable products the Product Information must be included with the product as a package insert.

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