ENFORTUMAB VEDOTIN

Information current as at: 1 July 2026

PBAC meeting date: November 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

Submission Details

Brand name:: PADCEV®
Form and strength:: Powder for I.V. infusion 20 mg

Powder for I.V. infusion 30 mg
Submission sponsor:: ASTELLAS PHARMA AUSTRALIA PTY LTD
Condition/indication: (therapeutic use): Muscle-invasive bladder cancer (MIBC)
Listing requested:: To request listing of enfortumab vedotin in combination with pembrolizumab for the perioperative treatment (i.e. before and after surgery) of patients with non-metastatic MIBC who have agreed to undergo radical cystectomy (bladder removal surgery) and are ineligible for cisplatin-based chemotherapy.
Funding program:: PBS Section 100 (Efficient Funding of Chemotherapy)
Request authority level:: Authority Required (STREAMLINED)
PBAC Submission type:: Change to existing listing (–)
Comment:: --
Other PBAC consideration:: --

Submission received for:: November 2026 PBAC meeting
2Opportunity for consumer comment:: Open 22/07/2026 and close 16/09/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:: Has not yet commenced
7Government processes:: Has not yet commenced
8Medicine listed on the PBS:: Has not yet occurred

PBAC Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

a1276

Page last updated

23 July 2026

v.9.19