Sacituzumab GovitecanTRODELVY
Treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have progressive disease following two or more prior systemic therapies, at least one in the locally advanced or metastatic setting.
Decisions on record
- Meeting Mar 2025 Not recommended Unresectable locally advanced or metastatic triple-negative breast cancer
- Meeting Nov 2023 Not recommended Unresectable locally advanced or metastatic HR+ HER2- breast cancer (≥2 prior chemotherapy regimens)
- Meeting Jul 2023 Not recommended Hormone receptor-positive (HR+), human epidermal growth factor receptor-2 negative (HER2-) breast cancer
- Meeting Mar 2022 Recommended Breast cancer
- Meeting Nov 2021 Not recommended Breast cancer (triple negative, unresectable/metastatic)
Access path
- TGA registered · TRODELVY
TGA label narrower than the PBS population
- Nov 2021Not recommended
vs physician's choice of single-agent treatment (TPC)…
- ↻ resubmittedMar 2022Recommended
Comparator changed: physician's choice of single-agent treatment (TPC) consisting of…
- Jul 2023Recommended · restricted
Comparator changed: physician's choice of single-agent treatment (capecitabine…
- Nov 2023Not recommended
Comparator changed: treatment of physician's choice (TPC) consisting of eribulin…
- Mar 2025Not recommended
PBAC did not support the claim that current restriction wording would be misinterpreted by prescribers; considered…
From the public summary
6.1 The PBAC did not recommend an amendment to the listing of sacituzumab govitecan (SG) for the treatment of patients with unresectable locally advanced or mTNBC to include a definition for HER2 status in the clinical criteria of the initial treatment phase restriction.PSD · Mar 2025
6.2 The PBAC did not support the submission’s claim that the current restriction wording was likely to be misinterpreted by prescribers when determining patient eligibility for PBS-subsidised treatment with SG. The PBAC advised that the current restriction wording along with the treatment guidelines outlining the line of therapy in this 14 paragraph 4.6, Trastuzumab Deruxtecan, Public Summary Document (PSD), [November 2023] PBAC Meeting 7PSD · Mar 2025
5.8 As a Category 3 submission, the economic analysis has not been independently evaluated.PSD · Mar 2025
5.9 The submission claimed that amending the restrictions would not change the uptake or cost-effectiveness of the existing arrangements, and therefore did not provide any economic modelling.PSD · Mar 2025
4.7 The PBAC reaffirmed that based on the available data, the claim that SG is of superiorPSD · Nov 2023
5.8 The PBAC recalled that in TROPiCS-02 the SG arm had higher rates of grade 3 or higher treatment emergent adverse events (TEAEs), treatment related TEAEs, treatment emergent treatment related SAEs, and TEAEs leading to dose interruption or discontinuation. Overall, the PBAC reaffirmed its view from July 2023 that SG has inferior safety compared with TPC (para 7.8, SG PSD, July 2023 PBAC meeting).PSD · Nov 2023
5.2 The PBAC noted and welcomed the input from Rare Cancers Australia (RCA) and the Medical Oncology Group of Australia (MOGA) via the Consumer Comments facility on the PBS website. While not specific to the request made in this submission, the PBAC noted the RCA consumer comment sought to provide insights into the broader context of breast cancer treatment and patient care.PSD · Mar 2025
5.3 The submission’s primary claim was that the current restriction wording has the potential to lead to misinterpretation and confusion of a patient’s eligibility for SG.PSD · Mar 2025
Cost-effectiveness
Category 3 submission; no economic modelling undertaken or required. Submission claimed no change to cost-effectiveness or uptake.
The submission claimed that amending the restrictions would not change the uptake or cost-effectiveness of the existing arrangements, and therefore did not provide any economic modelling. PSD · 2025
Decision context
PopulationAdult patients with unresectable locally advanced or metastatic triple-negative breast cancer (HER2-negative defined as IHC 0, or HER2-low defined as IHC 1+ or IHC 2+ with negative ISH result) who have progressive disease following two or more prior systemic therapies (at least one in the locally advanced or metastatic setting) and ECOG performance status ≤1
Why it was knocked back
- PBAC did not support the claim that current restriction wording would be misinterpreted by prescribers; considered current wording with treatment guidelines sufficient for clinical discretion; noted the mechanism of action of SG does not target HER2 the same way as T-DXd, making the populations not equivalent
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2025 | Not recommended | — | — | Other |
| Nov 2023 | Not recommended | treatment of physician's choice (TPC), consisting of eribulin, capecitabine, gemcitabine or vinorelbine | $95k–115k | RCT · OS |
| Jul 2023 | Recommended · restricted | treatment of physician's choice (TPC) consisting of eribulin, capecitabine, gemcitabine, or vinorelbine | — | RCT · OS |
| Mar 2022 | Recommended | physician's choice of single-agent treatment (capecitabine, gemcitabine, eribulin or vinorelbine) | — | RCT · OS |
| Nov 2021 | Not recommended | physician's choice of single-agent treatment (TPC) consisting of capecitabine, gemcitabine, eribulin or vinorelbine | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| ASCENT | Ph 3 | 529 | Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain … | completed |
| TROPiCS-02 | Ph 3 | 543 | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment | completed |
Consumer voice
Rare Cancers Australia and the Medical Oncology Group of Australia provided input via the PBS Consumer Comments facility. While RCA's comment provided broader context on breast cancer treatment and patient care, MOGA expressed support for the requested change to listing.
The PBAC noted and welcomed the input from Rare Cancers Australia (RCA) and the Medical Oncology Group of Australia (MOGA) via the Consumer Comments facility on the PBS website. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds ECOG performance status ≤1 requirement and specifies progressive disease, not in TGA label.