DaratumumabDARZALEX
Treatment of transplant ineligible, newly diagnosed multiple myeloma in combination with lenalidomide and dexamethasone.
Decisions on record
- Meeting Mar 2025 Recommended Multiple myeloma, transplant ineligible, newly diagnosed (combination with lenalidomide and dexamethasone)
- Meeting Mar 2023 Not recommended Multiple myeloma; newly diagnosed transplant ineligible multiple myeloma (NDMM)
- Meeting May 2022 Recommended Amyloid light-chain (AL) amyloidosis, newly diagnosed, in combination with CyBorD no PSD
- Meeting Nov 2021 Not recommended Amyloid light-chain (AL) amyloidosis
- Meeting Jul 2021 Recommended Relapsed/refractory multiple myeloma
- Meeting Jul 2020 Recommended Multiple myeloma (MM)
- Meeting Nov 2019 Deferred Multiple myeloma (MM)
- Meeting Mar 2019 Not recommended DARATUMUMAB is indicated for use: in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. as monotherapy, for the treatment of patients with multiple myeloma who have re
1 earlier decision
- Nov 2017 Not recommended Relapsed/refractory multiple myeloma
Access path
- TGA registered · DARZALEX
TGA label equal than the PBS population
- Nov 2017Not recommended
vs bortezomib-dexamethasone (Bd) for DBd regimen…
- ↻ resubmittedMar 2019Recommended · restricted
Comparator changed: bortezomib-dexamethasone (Bd) for DBd regimen…
- Nov 2019Deferred
Comparator changed: bortezomib plus dexamethasone (Bd) for DBd; no specific comparator…
- Jul 2020Recommended · restricted
Comparator changed: bortezomib plus dexamethasone (Bd) → bortezomib plus dexamethasone
- Jul 2021Recommended · restricted
Comparator changed: bortezomib plus dexamethasone → daratumumab 16 mg/kg intravenous
- Nov 2021Not recommended
Comparator changed: daratumumab 16 mg/kg intravenous → Bortezomib, cyclophosphamide and…
- ↻ resubmittedMay 2022Recommended
Comparator changed: Bortezomib, cyclophosphamide and dexamethasone (CyBorD) → CyBorD…
- Mar 2023Not recommended
Comparator changed: CyBorD (bortezomib, cyclophosphamide and dexamethasone) →…
- ↻ resubmittedMar 2025Recommended · restricted
Comparator changed: lenalidomide and dexamethasone (Ld) and bortezomib, lenalidomide and…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended daratumumab for use in combination with lenalidomide and dexamethasone (DLd) for the treatment of transplant ineligible, newly diagnosed multiple myeloma (TI NDMM) on the basis that it should be available only under special arrangements under the Section 100 Program (Efficient Funding of 51PSD · Mar 2025
7.2 The PBAC is satisfied that daratumumab provides, for some patients, a significant improvement in efficacy over Ld and BLd.PSD · Mar 2025
6.46 The March 2025 resubmission presented a stepped economic evaluation and modelled cost-utility analysis based on evidence from a direct randomised trial (MAIA), i.e. DLd versus Ld, as the resubmission assumed BLd was non-inferior to Ld. A summary of the key components of the economic evaluation is presented in Table 17.PSD · Mar 2025
The approach remained largely the same as that in March 2023. 38PSD · Mar 2025
NDMM population. (paragraph 7.13, daratumumab PSD, March 2023).PSD · Mar 2025
For the MAIA trial, no new safety data, other than deaths, were presented in the March 2025 resubmission. A post- hoc analysis of safety in the SWOG s0777 trial by Durie et al 2022 where ≥ 65 years population was used as a proxy for transplant eligibility status was presented in the March 2025 resubmission.PSD · Mar 2025
6.4 The PBAC noted that advice received from Myeloma Australia, Rare Cancers Australia and the Leukaemia Foundation. Myeloma Australia and the Leukaemia Foundation stated that daratumumab was associated with longer remission periods and was efficacious and well tolerated. Rare Cancers Australia stated that PBS listing of daratumumab would provide a more equitable and accessible treatment pathway for patients.PSD · Mar 2025
6.5 The PBAC recalled the March 2023 advice received from Myeloma Australia, MSAG and the Haematology Society of Australia and New Zealand (HSANZ) clarifying the likely use of daratumumab in clinical practice. The PBAC specifically noted the advice that the use of daratumumab may improve PFS, OS and quality of life and has a favourable side effect profile.PSD · Mar 2025
Cost-effectiveness
ICER not stated in the public text; redacted or confidential
Decision context
PopulationPatients with transplant ineligible, newly diagnosed multiple myeloma, receiving daratumumab in combination with lenalidomide and dexamethasone.
Risk sharingA combined Risk Share Arrangement for daratumumab across the TI NDMM (DLd) and second line MM (DBd) populations is proposed, accounting for utilisation of DLd in the TI NDMM population and DBd for second line MM.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Recommended · restricted | lenalidomide and dexamethasone (Ld); bortezomib, lenalidomide and dexamethasone (BLd) | — | RCT · PFS |
| Mar 2023 | Not recommended | lenalidomide and dexamethasone (Ld) and bortezomib, lenalidomide and dexamethasone (BLd) | — | RCT · PFS |
| May 2022 | Recommended | CyBorD (bortezomib, cyclophosphamide and dexamethasone) | — | RCT · Haematological response, organ response, MOD-PFS, OS |
| Nov 2021 | Not recommended | Bortezomib, cyclophosphamide and dexamethasone (CyBorD) | — | RCT · OS |
| Jul 2021 | Recommended · restricted | daratumumab 16 mg/kg intravenous | — | RCT · Surrogate |
| Jul 2020 | Recommended · restricted | bortezomib plus dexamethasone | — | RCT |
| Nov 2019 | Deferred | bortezomib plus dexamethasone (Bd) | — | RCT · PFS |
| Mar 2019 | Recommended · restricted | bortezomib plus dexamethasone (Bd) for DBd; no specific comparator for monotherapy | — | RCT · PFS |
| Nov 2017 | Not recommended | bortezomib-dexamethasone (Bd) for DBd regimen; lenalidomide-dexamethasone (Ld) for DLd regimen | — | RCT · PFS |
Consumer voice
The PBAC received consumer input from 144 individuals, 10 health care professionals, and 3 organisations via the PBS website Consumer Comments facility, as well as input from 100 individuals through a previous submission.
The PBAC noted and welcomed the input from individuals (144), health care professionals (10) and organisations (3) via the Consumer Comments facility on the PBS website. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation specify transplant-ineligible, newly diagnosed multiple myeloma with lenalidomide and dexamethasone combination.