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 the listing of durvalumab for the perioperative treatment of gastric cancer or gastroesophageal junction cancer (GC/GOJC) in patients who are eligible for neoadjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) chemotherapy, on the basis that it should be available only under special arrangements under Section 100 (Efficient Funding of Chemotherapy Program).PSD · Mar 2026
7.2 The PBAC considered that the proposed clinical place for durvalumab was well-defined, supported by the clinical evidence, and consistent with local and international guidelines.PSD · Mar 2026
6.33 The submission presented a stepped economic evaluation of perioperative D + FLOT compared with FLOT only for the treatment of resectable stage II-IVA GC/GOJC, over a 25-year time horizon. The modelled evaluation presented a cost-utility approach, consistent with the clinical claims that D + FLOT is superior to FLOT only in terms of both OS and EFS, with inferior safety.PSD · Mar 2026
6.34 Table 8 summarises the key components of economic evaluation. 19 OFFICIALPSD · Mar 2026
6.29 The submission described D + FLOT as superior in terms of effectiveness compared to Pbo + FLOT. The evaluation considered this claim was adequately supported but the magnitude of the effect is unclear, the key issue being the difference in the use of subsequent IO compared with Australian clinical practice.PSD · Mar 2026
6.30 The submission described D + FLOT as inferior in terms of safety compared to Pbo + FLOT. The ESC agreed with the evaluation that this claim was adequately supported.PSD · Mar 2026
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) | $55k–75k | 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.
Listed in law
PBS listings commencing 1 Mar 2020 were made by these 2 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 14 of 2020 | 27 Feb 2020 | Repealed | PDF ↗ |
| PB 15 of 2020 | 27 Feb 2020 | Repealed | PDF ↗ |