ENFORTUMAB VEDOTIN

Brand name:

• Padcev®

Form and strength:

Please search for and view the medicine's Public Summary Document (PSD) for more information

Submission sponsor:

ASTELLAS PHARMA AUSTRALIA PTY LTD

Condition/indication:
(therapeutic use)

• Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer (la/mUC)

Listing requested:

Please see PSD for more information

Funding program:

Please see PSD for more information

Request authority level:

Please see PSD for more information

PBAC Submission type:

Change to existing listing (Category 2)

Comment:

--

Other PBAC consideration:

--

Submission received for:

November 2024 PBAC meeting

Opportunity for consumer comment:

Open 31/07/2024 and close 25/09/2024 (see PBS Website)

PBAC meeting:

Held on 06/11/2024

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

03/12/2024

Lodgement of required documentation:

09/01/2025

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 15/06/2026

Status:

Finalised

7Government processes:

Commenced on 19/06/2026

8Medicine listed on the PBS:

Has not yet occurred