BLINATUMOMAB

Information current as at: 1 October 2026

Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Blincyto®
Form and strength:
  • Powder for I.V. infusion 38.5 micrograms
Submission sponsor:
AMGEN AUSTRALIA PTY LIMITED
Condition/indication:
(therapeutic use)
  • Acute lymphoblastic leukaemia (ALL) Precursor B-cell ALL (Pre-B-cell ALL)
Listing requested:
To request revision of the current combined blinatumomab/inotuzumab ozogamicin Risk Sharing Arrangement (RSA) for ALL and Pre-B-cell ALL.
Funding program:
PBS Section 100 (Efficient Funding of Chemotherapy)
Request authority level:
Authority Required
PBAC Submission type:
Change to existing listing (Category 3)
Comment:
--
Other PBAC consideration:
--

Progress Details

Submission received for:
July 2026 PBAC meeting
Opportunity for consumer comment:
Open 25/03/2026 and close 20/05/2026 (see PBS Website)
PBAC meeting:
Held on 08/07/2026
PBAC outcome published:
Recommended (see PBAC Outcomes)
Notice of intent submitted:
01/08/2026
Lodgement of required documentation:
10/08/2026
Acceptance of complete documentation:
Accepted
Agreement to listing arrangements:
Commenced on 18/08/2026
Status:
Finalised
7Government processes:
Commenced on 18/08/2026
8Medicine listed on the PBS:
Has not yet occurred
Glossary

PBAC Outcome

PBAC Recommendation:

The PBAC advised that it would be appropriate to increase the subsidisation caps under the existing blinatumomab Risk Sharing Arrangement (RSA) to account for additional utilisation of blinatumomab to treat minimum residual disease (MRD)‑negative paediatric B-precursor acute lymphoblastic leukaemia (B‑ALL).

Public Summary Document:
Not yet available
Case ID
1215
Page last updated
30 September 2026
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