AMIVANTAMAB

Information current as at: 1 July 2026

Legend: Completed N In progress Not applicable N Yet to commence

Submission Details

Brand name:
  • Rybrevant®
Form and strength:

Please search for and view the meeting agenda from the relevant meeting for more information

Submission sponsor:
JANSSEN-CILAG PTY LTD
Condition/indication:
(therapeutic use)
  • Non-small cell lung cancer (NSCLC)
Listing requested:
Please see meeting agenda for more information
Funding program:
PBS General Schedule
Request authority level:
Please see meeting agenda for more information
PBAC Submission type:
Change to existing listing (Category 2)
Comment:
--
Other PBAC consideration:
--

Progress Details

Submission received for:
March 2026 PBAC meeting
Opportunity for consumer comment:
Open 19/11/2025 and close 21/01/2026 (see PBS Website)
PBAC meeting:
Held on 11/03/2026
PBAC outcome published:
Recommended (see PBAC Outcomes)
Notice of intent submitted:
02/06/2026
5Lodgement of required documentation:
12/06/2026
Acceptance of complete documentation:
Under consideration
6Agreement to listing arrangements:
Has not yet commenced
7Government processes:
Has not yet commenced
8Medicine listed on the PBS:
Has not yet occurred

PBAC Outcome

PBAC Recommendation:

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 during or after treatment with osimertinib, a medicine commonly used for patients with EGFRm NSCLC. 

The PBAC welcomed input from individuals, health care professionals and organisations. Input from individuals expressed hope that amivantamab could improve quality of life and prolong survival noting that there were significant negative side-effects such as lethargy, pain, difficulty breathing and reduced mobility associated with currently available treatment options. Input from health care professionals indicated that amivantamab would provide meaningful benefits for patients, helping people live longer and slowing the progression of their disease.

The PBAC considered that the patient population most likely to be treated with amivantamab would have similar characteristics (patients who are otherwise well but whose cancer is widespread) to the patient population that is currently treated with atezolizumab plus bevacizumab with carboplatin and paclitaxel (ABCP), a currently available treatment option. 

The PBAC considered that based on the clinical evidence presented in the submission, amivantamab in combination with PDC was more effective than a currently available treatment option of PDC alone. The PBAC considered the benefit was modest and was associated with increased adverse events. 

However, the PBAC noted there was not enough clinical data available to determine whether amivantamab in combination with PDC provides additional benefit to patients compared with the existing treatment ABCP.  In this context, the PBAC considered that amivantamab for the treatment of EGFRm patients would be cost-effective if its price was based on the price of atezolizumab plus bevacizumab for the treatment of patients with non-squamous NSCLC, which includes patients with EGFRm. The PBAC considered amivantamab would be cost effective with a cost per 3-week treatment cycle no higher than that for atezolizumab plus bevacizumab. The PBAC considered the estimated number of patients who would be eligible for treatment with amivantamab presented in the submission was reasonable, but the submission overestimated the number of patients who would use the medicine.

Public Summary Document:
Not yet available

Case ID
a1148
Page last updated
30 June 2026
v.9.19