RomidepsinIstodax
Treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) following at least one prior systemic therapy.
Decisions on record
- Meeting Mar 2026 Recommended Relapsed or refractory peripheral T-cell lymphoma
- Meeting Dec 2017 Deferred Relapsed or refractory peripheral T-Cell lymphoma (PTCL)
- Meeting Nov 2016 Not recommended Relapsed or refractory peripheral T-cell lymphoma
Access path
- TGA registered · Istodax
TGA label equal than the PBS population
- Nov 2016Not recommended
vs no active therapy
- Dec 2017Deferred
- Mar 2026Recommended · restricted
Comparator changed: no active therapy → pralatrexate
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Section 100 Efficient Funding of Chemotherapy Program listing of romidepsin for the treatment of patients with relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL). The PBAC considered that despite the uncertainties associated with the clinical comparison presented in the submission, it was likely that romidepsin provided similar health outcomes to pralatrexate in the proposed population.PSD · Mar 2026
7.2 The PBAC noted that PTCL is a heterogenous group of rare cancers, that relapse is common, and that median survival for patients who relapse is low. The PBAC considered there is a high clinical need for additional therapies for R/R PTCL and noted the strong support for romidepsin in the consumer inputs received.PSD · Mar 2026
6.30 The submission presented a CMA comparing romidepsin with pralatrexate. The key components and assumptions used in the approach are shown in Table 9.PSD · Mar 2026
Table 9: Key components and assumptions of the cost-minimisation approach Component Claim or assumption Clinical claim: effectiveness Effectiveness is assumed to be non-inferior to pralatrexate.PSD · Mar 2026
6.24 The submission claimed that, compared to pralatrexate, romidepsin is associated with non-inferior effectiveness and different, but non-inferior safety.PSD · Mar 2026
6.25 The ESC agreed with the evaluation that the claim with regard to efficacy was not adequately supported by the data presented.PSD · Mar 2026
6.5 The resubmission stated (p17) that the analysis referred to in the November 2016 PSD was a comparison of overall survival of PTCL patients given a “treatment career” which includes romidepsin compared to a treatment career which does not include romidepsin, and clarifies that, in the continued absence of comparative studies, “the intention of Section 2 (of the submission) is to present the same external control data comparison as was presented to the …PSD · Dec 2017
6.6 The resubmission was based on one phase II study (0002) and individual patient data sourced from three international databases: 6PSD · Dec 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated
Listing was requested on the basis of a cost-minimisation approach (CMA) versus pralatrexate. PSD · 2026
Decision context
PopulationAdult patients with relapsed or refractory peripheral T-cell lymphoma (including AITL, ALCL, PTCL-NOS) who have received at least one prior systemic therapy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | pralatrexate | — | Single-arm · ORR |
| Dec 2017 | Deferred | no active therapy | — | Single-arm · OS |
| Nov 2016 | Not recommended | no active therapy | — | Single-arm · ORR |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| Study 0002 (GPI-06-0002) | Ph 2 | 131 | Percentage of Participants With a Complete Response According to the International Worksho… | completed |
Consumer voice
One individual provided input via the PBS website Consumer Comments facility, noting the importance of access to medicines for patients.
noting the importance of access to medicines for patients Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both restrict to relapsed/refractory PTCL after at least one prior systemic therapy; PBAC's 'later-line' and 'chemotherapy-refractory' language clarifies but does not narrow the TGA label.
Listed in law
PBS listings commencing 1 Jul 2026 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 70 of 2026 | 11 Jun 2026 | In force | PDF ↗ |
| PB 73 of 2026 | 30 Jun 2026 | In force | PDF ↗ |
| PB 74 of 2026 | 30 Jun 2026 | In force | PDF ↗ |