DurvalumabImfinzi
Perioperative treatment (neoadjuvant and adjuvant) of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma who are eligible for neoadjuvant FLOT chemotherapy.
Decisions on record
- Meeting Mar 2026 Recommended Gastric cancer (GC) or gastro-oesophageal junction cancer (GOJC)
- Meeting Nov 2025 Recommended Muscle-invasive bladder cancer – perioperative treatment before and after surgery in patients eligible for cisplatin-based chemotherapy
- Meeting Jul 2025 Recommended Limited-stage small cell lung cancer not progressed on/after chemoradiation
- Meeting Jul 2023 Recommended Biliary tract cancer
- Meeting Mar 2023 Not recommended Biliary tract cancer (BTC); advanced biliary tract cancer
- Meeting Nov 2022 Noted Small cell lung cancer no PSD
- Meeting Mar 2022 Recommended Unresectable Stage III, non-small cell lung cancer
- Meeting Nov 2020 Recommended Small cell lung cancer (SCLC)
4 earlier decisions
- Nov 2019 Recommended Non-small cell lung cancer (NSCLC)
- Jul 2019 Not recommended Urothelial cancer
- Jul 2019 Not recommended Durvalumab is indicated for use: in patients with locally advanced or metastatic urothelial carcinoma who: o have disease progression during or following platinum- containing chemotherapy. o have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-
- Nov 2018 Not recommended Non-small cell lung cancer
Access path
- TGA registered · Imfinzi
TGA label narrower than the PBS population
- Nov 2018Not recommended
vs placebo (watch-and-wait monitoring plus best supportive…
- Jul 2019Not recommended
Comparator changed: placebo (watch-and-wait monitoring plus best supportive care) →…
- Jul 2019Not recommended
Comparator changed: placebo (watch-and-wait monitoring plus best supportive care) →…
- ↻ resubmittedNov 2019Recommended · restricted
Comparator changed: pembrolizumab → best supportive care (watch-and-wait monitoring plus…
- Nov 2020Recommended · restricted
Comparator changed: best supportive care (watch-and-wait monitoring plus best supportive…
- Mar 2022Recommended
Comparator changed: atezolizumab in combination with etoposide plus platinum-based…
- Mar 2023Recommended · restricted
Comparator changed: durvalumab 10 mg/kg Q2W regimen → placebo + gemcitabine and cisplatin
- Jul 2023Recommended · restricted
Comparator changed: placebo + gemcitabine and cisplatin → placebo in combination with…
- Jul 2025Recommended · restricted
Comparator changed: placebo in combination with gemcitabine and cisplatin → watch and…
- Nov 2025Recommended · restricted
Comparator changed: watch and wait monitoring plus best supportive care (represented by…
- Mar 2026Recommended · restricted
Comparator changed: Standard of care (gemcitabine plus cisplatin neoadjuvant chemotherapy…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended a Section 100 (Efficient Funding of Chemotherapy Program) (STREAMLINED) listing of durvalumab for the perioperative treatment (i.e. both before and after surgery) of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based neoadjuvant chemotherapy (NAC) and planning to undergo radical cystectomy (RC).PSD · Nov 2025
7.2 The PBAC noted the clinical need in MIBC as it is a challenging condition to treat with significant impacts on quality of life despite the current treatment options available.PSD · Nov 2025
6.40 The submission presented cost-effectiveness and cost-utility analyses based on the Phase 3 randomised controlled NIAGARA trial in MIBC, which compared neoadjuvant durvalumab with GC followed by RC and adjuvant durvalumab, versus NAC with GC followed by RC and post-surgery active surveillance.PSD · Nov 2025
6.41 The model measured outcomes in terms of life-years (LYs) gained and quality-adjusted life years (QALYs) gained. The key components of the cost utility analysis are presented in Table 13. 29 OFFICIALPSD · Nov 2025
Supplementary: Compared to standard of care in which some patients receive adjuvant nivolumab, perioperative durvalumab plus GC NAC has superior comparative efficacy and non-inferior safety. Source: Table 1-1, p16 of the submission.PSD · Nov 2025
Note: Clinical criteria for cisplatin eligibility: (1) ECOG performance status < 2; (2) creatinine clearance ≥60 mL/min; (3) no significant hearing loss (measured at audiometry of 25 dB at 2 contiguous frequencies); (4) less than Grade 2 peripheral neuropathy, and (5) no clinical evidence of NYHA class III or greater heart failure (Galsky MD et al. 2011).PSD · Nov 2025
6.2 The PBAC noted and welcomed the input from 3 organisations via the Consumer Comments facility on the PBS website. One individual also provided input expressing support for the PBS listing of durvalumab, but specially in relation to endometrial cancer, not MIBC.PSD · Nov 2025
6.3 The Medical Oncology Group Australia (MOGA) indicated their strong support for the PBS listing of durvalumab to be extended to perioperative treatment of patients with MIBC. The MOGA categorised durvalumab as one of the therapies of ‘highest priority for PBS listing’ on the basis of the NIAGARA trial.PSD · Nov 2025
Cost-effectiveness
ICER value redacted in PSD; marked as commercially sensitive ('redacted content').
The resubmission provided an economic model with a time horizon of 7.5 years, use of a different value set to calculate utility values, altered public/private hospital proportions and a reduced price to arrive at an ICER of $55,000 to < $75,000 / QALY. PSD · 2023
Decision context
PopulationAdults with resectable gastric or gastroesophageal junction adenocarcinoma (Stage II or higher) eligible for neoadjuvant FLOT chemotherapy with ECOG performance status 0 or 1.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | standard of care FLOT regimen alone (neoadjuvant-adjuvant FLOT4) | — | RCT · EFS |
| Nov 2025 | Recommended · restricted | Standard of care (gemcitabine plus cisplatin neoadjuvant chemotherapy followed by active surveillance); adjuvant nivolum | — | RCT · EFS |
| Jul 2025 | Recommended · restricted | watch and wait monitoring plus best supportive care (represented by placebo infusion) | — | RCT · OS |
| Jul 2023 | Recommended · restricted | placebo in combination with gemcitabine and cisplatin | $55k–75k | RCT · OS |
| Mar 2023 | Recommended · restricted | placebo + gemcitabine and cisplatin | — | RCT · OS |
| Mar 2022 | Recommended | durvalumab 10 mg/kg Q2W regimen | — | Cost-minimisation · Cost-minimisation |
| Nov 2020 | Recommended · restricted | atezolizumab in combination with etoposide plus platinum-based chemotherapy | — | RCT · OS |
| Nov 2019 | Recommended · restricted | best supportive care (watch-and-wait monitoring plus best supportive care) | $15k–75k | RCT · OS |
| Jul 2019 | Not recommended | placebo or 'watch-and-wait' monitoring plus best supportive care | — | RCT · OS |
| Jul 2019 | Not recommended | pembrolizumab | — | Single-arm · ORR |
| Nov 2018 | Not recommended | placebo (watch-and-wait monitoring plus best supportive care) | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| TOPAZ-1 | Ph 3 | 810 | Overall Survival (OS) | active not recruiting |
| ADRIATIC | Ph 3 | 730 | Durvalumab Versus Placebo: Progression-Free Survival (PFS) Assessed by Blinded Independent… | active not recruiting |
| CASPIAN | Ph 3 | 987 | Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D … | active not recruiting |
| NIAGARA | Ph 3 | 1,063 | Pathologic Complete Response (pCR) Rates at Time of Cystectomy | active not recruiting |
Consumer voice
Four organisations and one individual provided input supporting PBS listing of durvalumab for muscle-invasive bladder cancer (MIBC) treatment. Consumer groups emphasised the need for perioperative treatment options to reduce metastasis risk and improve survival outcomes, noting that current treatments still carry a high risk of recurrence.
Rare Cancers Australia discussed how access to perioperative treatment will reduce the risk of metastases that cannot always be eliminated by surgery alone and that reported side effects can be managed with the support of general practitioners. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients eligible for cisplatin-based chemotherapy and ECOG ≤1; TGA label has no such eligibility criteria.