ElranatamabElrexfio
Treatment of patients with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Decisions on record
- Meeting Mar 2025 Recommended Relapsed or refractory multiple myeloma (RRMM), after ≥3 prior lines of therapy
- Meeting Jul 2024 Not recommended Relapsed or refractory multiple myeloma
Access path
- TGA registered · Elrexfio
TGA label narrower than the PBS population
- Jul 2024Not recommended
vs standard of care (SOC) comprising carfilzomib +…
- ↻ resubmittedDec 2025—
Comparator changed: standard of care (SOC) comprising carfilzomib + dexamethasone…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended elranatamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM) who have received at least three prior lines of therapy, on the basis that it should be available only under special arrangements under the Section 100 Program (Efficient Funding of Chemotherapy – Related Benefits) and as a General Schedule listing.PSD · Mar 2025
7.2 The PBAC was satisfied that elranatamab provides, for some patients, a significant improvement in efficacy over standard of care, represented by Cd, Pd and Sd.PSD · Mar 2025
The PBAC considered that the economic analysis presented in the Partially addressed. submission was highly uncertain due to the treatment effect in the model, Treatment effects included in the model were which was informed by the IPTW analysis of MagnetisMM-3 and COTA, based on the ITCs versus the nominated SOC being highly uncertain given the substantive transitivity issues across the (Cd, Pd and Sd).PSD · Mar 2025
The PBAC noted the comparator arm was costed based on an assumed Addressed. basket of therapies and weightings which may not reflect the pattern of The distribution of use for the SOC therapies was replacement/displacement with elranatamab, and there was likely limited derived from an analysis of PBS data provided by overlap of the basket of therapies with the treatments used in COTA the DUSC Secretariat (100% PBS sample). (paragraph 7.16).PSD · Mar 2025
6.56 The submission described elranatamab as superior in terms of effectiveness and non- inferior but different in terms of safety compared to standard of care, represented by Cd, Pd and Sd.PSD · Mar 2025
6.57 The therapeutic conclusion presented in the submission was partially supported by the ESC, as outlined below:PSD · Mar 2025
The comments from individuals, the majority of whom would like access to elranatamab, described the clinical need for effective treatments for multiple myeloma. The individuals stated that elranatamab is a beneficial treatment option and potentially results in improved response rates and progression free and overall survival outcomes.PSD · Mar 2025
6.4 Input was also received from Myeloma Australia, the Leukaemia Foundation and Rare Cancers Australia. Myeloma Australia and the Leukaemia Foundation stated that elranatamab was a new class of therapy which was efficacious and well tolerated. Rare Cancers Australia stated that PBS listing of elranatamab would provide a more equitable and accessible treatment pathway for patients.PSD · Mar 2025
Cost-effectiveness
ICER value(s) not disclosed in the public summary document; the document states the base case ICER 'remained high' but does not provide numeric values
The base case ICER remained high and was highly sensitive to inputs including the time horizon, treatment effect and distribution of standard of care. PSD · 2025
Decision context
PopulationAdults with relapsed or refractory multiple myeloma who have received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2025 | — | Standard of care (carfilzomib + dexamethasone 51.0%, pomalidomide + dexamethasone 46.5%, selinexor + dexamethasone 2.5%) | — | RCT · ORR |
| Jul 2024 | Not recommended | standard of care (SOC) comprising carfilzomib + dexamethasone, pomalidomide + dexamethasone, elotuzumab + lenalidomide + | — | Single-arm · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| MagnetisMM-3 | Ph 2 | 187 | Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) as Per Internat… | active not recruiting |
| MagnetisMM-5 | Ph 3 | 944 | Part 1 Safety Lead-In: Incidence of dose limiting toxicities | recruiting |
Consumer voice
Consumer input from 163 individuals, 3 healthcare professionals, and 3 organisations supported access to elranatamab for multiple myeloma, describing it as an effective treatment with manageable side effects and potential for improved survival outcomes, while noting its prohibitive cost. Healthcare professionals highlighted its fast-acting nature, sustained response, lack of need for concomitant d
The individuals stated that elranatamab is a beneficial treatment option and potentially results in improved response rates and progression free and overall survival outcomes. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — TGA requires disease progression on last therapy; PBAC omits this requirement, creating a narrower TGA population.