TalazoparibTalzenna
First-line treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with BRCA1/2 pathogenic variants who have not received prior treatment with a novel hormonal agent.
Decisions on record
- Meeting Jul 2024 Recommended Metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutation
- Meeting Mar 2024 Not recommended Metastatic castration-resistant prostate cancer (mCRPC)
- Meeting Nov 2019 Not recommended Advanced breast cancer
Access path
- TGA registered · Talzenna
TGA label narrower than the PBS population
- Nov 2019Not recommended
vs single-agent chemotherapy (capecitabine, eribulin…
- Mar 2024Not recommended
Comparator changed: single-agent chemotherapy (capecitabine, eribulin, gemcitabine…
- ↻ resubmittedJul 2024Recommended
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the listing of talazoparib, for use in combination with enzalutamide, for the first line treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with breast cancer gene (BRCA)1/2 pathogenic variants who have not received prior treatment with a novel hormonal agent (NHA).PSD · Jul 2024
5.2 The PBAC acknowledged that the Medical Oncology Group of Australia (MOGA) again expressed its support for the resubmission.PSD · Jul 2024
Present a proposal to join the current olaparib RSA The early re-entry resubmission agreed in principle to Yes (paragraph 7.16, March 2024 PSD) join the current olaparib monotherapy RSA. Source: March 2024 talazoparib PSD.PSD · Jul 2024
4.9 At the March 2024 PBAC meeting, the PBAC advised that the economic model should be revised as per the pre-PBAC response so that: • The time horizon was reduced from 10 to 7.5 years;PSD · Jul 2024
6.39 The submission described talazoparib + enzalutamide as superior in terms of effectiveness and inferior in terms of safety when compared to enzalutamide alone in patients with a BRCA1/2 pathogenic variant.PSD · Mar 2024
6.40 The ESC considered that the claim of superior efficacy was supported by evidence presented; however, the magnitude of effect was uncertain. For rPFS and OS, the submission relied on data from the BRCA1/2 subgroup of Cohort 2 and while this was an appropriate population, the evidence was from a small subgroup and so was not subject to the same hypothesis testing as the overall trial.PSD · Mar 2024
4.2 The PBAC noted that the Medical Oncology Group of Australia (MOGA) again expressed its support for the talazoparib submission. The PBAC noted that the MOGA stated that an ESMO-MCBS score for the BRCA1/2 subgroup could not be determined as the subgroup did not meet the ESMO-MCBS requirements.2PSD · Jul 2024
4.3 The PBAC recalled that in March 2024 Rare Cancers Australia also supported the submission, describing the need for earlier and more effective treatments for patients with BRCA1/2 variants. Clinical evidence and claimPSD · Jul 2024
Cost-effectiveness
The resubmission proposed an effective EMP for talazoparib of $ . When this was applied in conjunction with the changes requested by PBAC in March 2024, it resulted in an ICER of $55,000 to < $75,000 per QALY. PSD · 2024
Decision context
PopulationAdult patients diagnosed with mCRPC with BRCA1/2 pathogenic variants who have not been previously treated with a novel hormonal agent, with ECOG performance score ≤1.
Risk sharingRisk sharing arrangement (RSA) — agreed in principle to join the current olaparib monotherapy RSA.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2024 | Recommended | enzalutamide monotherapy | $55k–75k | RCT · PFS |
| Mar 2024 | Not recommended | enzalutamide monotherapy | — | RCT · PFS |
| Nov 2019 | Not recommended | single-agent chemotherapy (capecitabine, eribulin, gemcitabine, vinorelbine) | — | RCT · PFS |
Clinical evidence
Codependent tests
| Service | Biomarker | MSAC outcome | Year |
|---|---|---|---|
| BRCA1/2 mutation testing in patients with metastatic castration-resistant prostate cancer (amendment to MBS items 73303 and 73304) | BRCA1/2 pathogenic or likely pathogenic gene variants | supported | 2024 |
Consumer voice
Two organisations—Medical Oncology Group of Australia (MOGA) and Rare Cancers Australia—expressed support for the talazoparib submission, with Rare Cancers Australia emphasising the need for earlier and more effective treatments for patients with BRCA1/2 variants.
the MOGA stated that an ESMO-MCBS score for the BRCA1/2 subgroup could not be determined as the subgroup did not meet the ESMO-MCBS requirements. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to BRCA1/2 variants and first-line setting; TGA label covers all HRR mutations without line restriction.