BELANTAMAB MAFODOTIN
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Blenrep®
- Form and strength:
-
- Powder for injection 70 mg (50 mg per ml)
- Powder for injection 100 mg (50 mg per ml)
- Submission sponsor:
- GLAXOSMITHKLINE AUSTRALIA PTY LTD
- Condition/indication:
(therapeutic use) -
- Relapsed and/or refractory multiple myeloma (MM)
- Listing requested:
- Resubmission to request listing of belantamab mafodotin for use in combination with bortezomib and dexamethasone for the treatment of relapsed and/or refractory MM in patients who have progressive disease after at least one prior line of therapy. This item was previously considered by the PBAC at its November 2025 meeting.
- Funding program:
- PBS Section 100 (Efficient Funding of Chemotherapy)
- Request authority level:
- Authority Required (Telephone/Online)
- PBAC Submission type:
- New PBS listing (Standard Re-entry Pathway)
- 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
-
5Lodgement of required documentation:
- 21/08/2026
-
Acceptance of complete documentation:
- Under consideration
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended subsidy of belantamab mafodotin (Blenrep®) through the PBS, for use in combination with bortezomib and dexamethasone (BmBd) for the treatment of multiple myeloma that has returned or is not responding to treatment, specifically relapsed and/or refractory multiple myeloma (RRMM). The PBAC welcomed input from individuals, health professionals and organisations which strongly supported the resubmission and highlighted the longer survival time associated with BmBd.
The PBAC considered the proposed use of BmBd in patients who have received at least one prior treatment for RRMM was appropriate. The PBAC accepted that BmBd was more effective at delaying disease progression and extending patients’ lives compared to current standards of care including daratumumab (in combination with bortezomib and dexamethasone) and carfilzomib (in combination with dexamethasone). The PBAC again noted that belantamab mafodotin was associated with side effects that affected the eyes, including blurred vision, dry eye and visual impairment that affected a patients ability to read and drive.
The PBAC considered that BmBd would provide value for money at a lower price. The PBAC considered the Sponsor’s updated estimation of how many patients would use BmBd was appropriate and advised a risk sharing arrangement was appropriate.