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
ICER rose $95,000 → $255,000 (+168%)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of amivantamab, in combination with platinum- based doublet chemotherapy (PDC), for the 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, on the basis that it should be available only under special arrangements under Section 100 - Efficient Funding of Chemotherapy …PSD · Mar 2026
OFFICIAL Public Summary Document - March 2026 PBAC Meeting considered the estimated number of eligible patients presented in the submission was reasonable, but uptake was substantially overestimated.PSD · Mar 2026
6.41 The submission presented a modelled cost utility analysis (CUA) using a three-state partitioned survival model over a seven-year time horizon, comparing AmiCP with CP.PSD · Mar 2026
Additionally, the same model was used to generate an ICER for AmiCP vs ABCP. The base case ICER in the submission was calculated as a weighted ICER applying aPSD · Mar 2026
6.36 The submission claimed AmiCP is superior in terms of effectiveness compared with CP.PSD · Mar 2026
The ESC considered this claim is adequately supported based on the statistically significant difference in PFS (HR=0.48; 95% CI: 0.36, 0.64; p<0.0001), OS (HR=0.73; 95% CI: 0.54, 0.99; p=0.0386), ORR (OR=3.1; 95% CI: 2.00, 4.80; p<0.0001) and icPFS (HR=0.65; 95% CI: 0.49, 0.84; nominal p=0.0012) for AmiCP compared to CP presented in the MARIPOSA-2 trial.PSD · Mar 2026
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) | $155k–255k | RCT · PFS |
| Nov 2024 | Recommended | platinum-based chemotherapy (carboplatin and pemetrexed) | $75k–95k | 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.
Listed in law
PBS listings commencing 1 May 2025 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 40 of 2025 | 28 Apr 2025 | Repealed | PDF ↗ |
| PB 41 of 2025 | 28 Apr 2025 | Repealed | PDF ↗ |
| PB 42 of 2025 | 28 Apr 2025 | Repealed | PDF ↗ |