AMIVANTAMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Rybrevant SC®
- Form and strength:
-
- Solution for subcutaneous injection 1600 mg in 10 mL
- Solution for subcutaneous injection 2240 mg in 14 mL
- Solution for subcutaneous injection 2400 mg in 15 mL
- Solution for subcutaneous injection 3520 mg in 22 mL
- Submission sponsor:
- JANSSEN-CILAG PTY LTD
- Condition/indication:
(therapeutic use) -
- Non-small cell lung cancer (NSCLC)
- Listing requested:
- To request listing of a new subcutaneous form of amivantamab for the first-line treatment (in combination with platinum-based chemotherapy) and second-line treatment (as monotherapy) of adult patients with locally advanced or metastatic NSCLC with an epidermal growth factor receptor gene mutation.
- Funding program:
- PBS General Schedule PBS Section 100 (Efficient Funding of Chemotherapy)
- Request authority level:
- Authority Required (Telephone/Online)
- PBAC Submission type:
- New PBS listing (Category 2)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
5Lodgement of required documentation:
-
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
The PBAC recommended subsidy of a subcutaneous (SC) injection form of amivantamab through the PBS for the treatment of locally-advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion positive mutation.
The PBAC welcomed input received from consumers and acknowledged that an SC presentation of amivantamab may reduce the time-burden associated with cancer care.
The PBAC considered the amivantamab regimen delivered subcutaneously provided the same benefits as the amivantamab regimen delivered intravenously.
The PBAC considered the subcutaneous form of amivantamab would be value for money if it cost the same as intravenous amivantamab. The PBAC noted that listing amivantamab SC on the PBS would not result in an increase to government expenditure.