PEMBROLIZUMAB

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:: Keytruda SC®
Form and strength:: Solution for subcutaneous injection containing pembrolizumab 395 mg in 2.4 mL vial

Solution for subcutaneous injection containing pembrolizumab 790 mg in 4.8 mL vial
Submission sponsor:: MERCK SHARP & DOHME (AUSTRALIA) PTY LTD
Condition/indication: (therapeutic use): Cancer
Listing requested:: To request listing of a new subcutaneous form of pembrolizumab (in two different strengths) under the same circumstances and for the same indications as the currently listed intravenous form.
Funding program:: PBS General Schedule PBS Section 100 (Efficient Funding of Chemotherapy)
Request authority level:: Authority Required (STREAMLINED)
PBAC Submission type:: New PBS 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

a1297

Page last updated

23 July 2026

v.9.19