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)

• Urothelial cancer

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:

New listing (Early Re-entry Pathway)

Comment:

This item was recommended out-of-session between the December 2022 Intracycle PBAC Meeting and the March 2023 PBAC Meeting

Other PBAC consideration:

• ENFORTUMAB VEDOTIN
• ENFORTUMAB VEDOTIN

Submission received for:

March 2023 PBAC meeting

Opportunity for consumer comment:

--

PBAC meeting:

Held on 08/03/2023

PBAC outcome published:

Recommended (see PBAC Outcomes)

Notice of intent submitted:

15/03/2023

Lodgement of required documentation:

30/03/2023

Acceptance of complete documentation:

Accepted

Agreement to listing arrangements:

Commenced on 11/05/2023

Status:

Finalised

Government processes:

Commenced on 03/07/2023

Medicine listed on the PBS:

01/10/2023 (see PBS schedule)