AmivantamabRYBREVANT
Treatment of patients with epidermal growth factor receptor gene mutated (EGFRm) locally advanced/metastatic non-small cell lung cancer (NSCLC) where the condition has progressed on or after osimertinib, in combination with platinum-based doublet chemotherapy.
Decisions on record
- Meeting Mar 2026 Recommended Non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene mutation, locally advanced or metastatic NSCLC with EGFR mutation with disease progression after osimertinib
- Meeting Nov 2024 Recommended Non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutation
Access path
- TGA registered · RYBREVANT
TGA label narrower than the PBS population
- Nov 2024Recommended
vs platinum-based chemotherapy (carboplatin and pemetrexed)
- Mar 2026Recommended · restricted
Comparator changed: platinum-based chemotherapy (carboplatin and pemetrexed) →…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of amivantamab, for the treatment of patients with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutation positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The PBAC considered it was reasonable for amivantamab to be available for patients in the first- and second-line setting.PSD · Nov 2024
7.2 The PBAC noted the input from individuals, health care professionals, Lung Foundation Australia, the International Cancer Advocacy Network’s Exon 20 Group, and Rare Cancers Australia emphasising the clinical need for effective treatment options for this population, given that patients have a poor prognosis and there is currently no other therapy that targets the EGFR ex20ins mutation.PSD · Nov 2024
6.43 The submission presented a stepped economic cost-effectiveness and cost-utility analysis based on the direct randomised trial, PAPILLON. A summary of the key components of the economic evaluation is presented in Table 9.PSD · Nov 2024
Table 9: Summary of model structure, key inputs and rationale Component Summary Treatments ACP vs CP Type of analysis Cost-effectiveness analysis and cost-utility analysisPSD · Nov 2024
6.39 The submission claimed that in patients with treatment-naive, locally advanced or metastatic NSCLC with evidence of EGFR ex20ins mutation, ACP was superior in effectiveness and inferior but manageable in safety compared to CP.PSD · Nov 2024
6.40 The PBAC agreed with the ESC that the claim of superior effectiveness in patients with metastatic (Stage IV) NSCLC was adequately supported based on the primary outcome, PFS, in the PAPILLON trial.PSD · Nov 2024
6.3 The PBAC noted the advice received from the Rare Cancers Australia, Lung Foundation Australia and the International Cancer Advocacy Network’s Exon 20 Group supported the PBS listing of amivantamab for the treatment of patients with EGFR ex20ins mutation positive locally advanced or metastatic NSCLC.PSD · Nov 2024
6.4 The organisations noted that patients with EGFR ex20ins mutation positive NSCLC currently face particularly low survival rates and have limited treatment options, creating a significant burden for patients and their carers and relatives.PSD · Nov 2024
Cost-effectiveness
ICER value redacted; document states 'redacted content' in economic sections
Decision context
PopulationAdult patients with EGFRm locally advanced/metastatic (Stage IIIB-IV) NSCLC whose disease has progressed on or after osimertinib monotherapy in the advanced/metastatic setting, with WHO performance status ≤2
Risk sharingSpecial pricing arrangement applies; effective approved ex-manufacturer price (AEMP) per 350 mg vial is redacted
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | platinum-based doublet chemotherapy (PDC) and atezolizumab + bevacizumab + carboplatin + paclitaxel (ABCP) | — | RCT · PFS |
| Nov 2024 | Recommended | platinum-based chemotherapy (carboplatin and pemetrexed) | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| PAPILLON | Ph 3 | 308 | Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors … | active not recruiting |
Consumer voice
Consumer input from patients, healthcare professionals and advocacy organisations supported PBS listing of amivantamab for EGFR ex20ins mutation positive NSCLC, noting limited treatment options, low survival rates, clinically meaningful benefit from increased PFS, manageable side effects, and substantial financial pressures faced by patients.
patients with EGFR ex20ins mutation positive NSCLC currently face particularly low survival rates and have limited treatment options, creating a significant burden for patients and their carers and relatives. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status ≤2; TGA label lacks this performance status requirement.