Mirvetuximab SoravtansineElahere
Treatment of patients with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received at least one prior systemic treatment regimen and have high folate receptor alpha (FRα) tumour cell expression (≥75% of viable tumour cells with moderate [2+] and/or strong [3+] membrane staining).
Decisions on record
- Meeting Nov 2025 Recommended Platinum-resistant high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer with high FRα expression, ≥1 prior line of therapy no PSD
- Meeting Jul 2025 Deferred Platinum-resistant high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer with high FRα expression
Access path
- TGA registered · Elahere
TGA label narrower than the PBS population
- Nov 2025Recommended
vs non-platinum chemotherapy (paclitaxel, topotecan, or…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC deferred its consideration of mirvetuximab soravtansine (MIRV) for the treatment of patients with platinum-resistant high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, (EOC) who have received at least one prior systemic treatment regimen and have high folate receptor alpha (FRα) tumour cell expression.PSD · Jul 2025
7.2 The PBAC considered that there is a moderate clinical need for new therapies for platinum resistant EOC, noting the severity of symptoms and impact on patient quality of life. The PBAC also noted that currently available chemotherapy options are associated with significant side effects and are only modestly effective, with approximately 21% of patients alive at 5 years.PSD · Jul 2025
6.63 The submission presented a modelled cost-utility analysis (CUA) comparing MIRV to a mixed comparator (weighted 50:50) of ICC (based on direct evidence from MIRASOL) and BEVA + ICC (based on the indirect treatment comparison using evidence from MIRASOL and AURELIA) in a population of patients with PROC who have received at least one prior systemic treatment regimen and have high FRα expression (≥ 75% of tumour cells).PSD · Jul 2025
6.64 A summary of the model structure and key inputs for the economic evaluation is presented in Table 18. 31 OFFICIALPSD · Jul 2025
6.52 The submission claimed MIRV was superior in terms of effectiveness compared to ICC.PSD · Jul 2025
The evaluation considered that this claim appears to be adequately supported for OS (HR 0.68 [95% CI 0.543, 0.840] p=0.0004), noting the outcome was at risk of bias due to informative censoring which may have confounded trial results (paragraph 6.7).PSD · Jul 2025
6.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (1) and organisations (4) via the Consumer Comments facility on the PBS website. The comments described the impact and clinical outcomes for people living with ovarian cancer including burdensome symptoms, poor quality of life, and short life expectancy.PSD · Jul 2025
6.4 The Medical Oncology Group of Australia (MOGA) also expressed its strong support for the MIRV submission, categorising it as one of the therapies of “high priority for PBS listing” on the basis of the MIRASOL trial.PSD · Jul 2025
Cost-effectiveness
ICER values are redacted in the public summary document (shown as $ symbols)
Decision context
PopulationPatients with platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received at least one prior systemic treatment regimen and have high FRα tumour cell expression (≥75% of viable tumour cells with moderate [2+] and/or strong [3+] membrane staining) as determined by immunohistochemistry (IHC) testing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2025 | Recommended | non-platinum chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin) with or without bevacizumab | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| MIRASOL | Ph 3 | 453 | Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumor… | completed |
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| Immunohistochemistry testing for folate receptor alpha (FRα) expression in platinum-resistant ovarian cancer | folate receptor alpha (FRα) expression | deferred | 2025 |
Consumer voice
Consumer input from individuals and organizations described the burden of platinum-resistant ovarian cancer, including poor quality of life, serious side effects from current chemotherapy, and travel burden for treatment. Consumers emphasized the need for effective new targeted therapies with survival benefit and manageable side effects.
there are few effective treatments for platinum resistant EOC and emphasized the need for effective new therapies Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line treatment and requires quantified high FRα expression (≥75% with 2+/3+ staining), narrowing the TGA's one-to-three prior regimens.