TARLATAMAB
Information current as at: 1 November 2026
Submission Details
- Brand name:
-
- Imdelltra®
- Form and strength:
-
- Powder for injection 1mg, powder for injection 10 mg
- Submission sponsor:
- AMGEN AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Extensive-stage small cell lung cancer
- Listing requested:
- To reconsider a request for listing tarlatamab for the second-line and subsequent treatment of adult patients with extensive-stage small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy.
- Funding program:
- PBS Section 100 (Efficient Funding of Chemotherapy)
- Request authority level:
- Authority Required (STREAMLINED)
- PBAC Submission type:
- New PBS listing (Early resolution)
- Comment:
- --
- Other PBAC consideration:
Progress Details
-
Submission received for: - September 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 19/11/2025 and close 21/01/2026 (see PBS Website)
-
PBAC meeting: - Held on 04/09/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
5Lodgement of required documentation:
- Has not yet commenced
-
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 tarlatamab for the treatment of extensive-stage small cell lung
cancer (ES-SCLC) with disease progression on or after first line treatment with platinum-based
chemotherapy. The PBAC recalled the input it received from healthcare professionals
and individuals prior to its March 2026 meeting, and welcomed additional input provided
for this resubmission from a health care professional and an individual. The PBAC
noted that there was currently a high clinical need for effective therapies for ES-SCLC,
noting that patients currently have few effective treatment options, with only modest
clinical benefit, and typically face rapidly progressive disease, substantial symptom
burden, and short survival.
While the resubmission (using the early resolution pathway) addressed the outstanding
issues related to the restriction criteria and financial estimates, the PBAC noted
it did not implement the requested changes to the economic model requested in March
2026. The PBAC considered that a substantial price reduction was required to achieve
a cost-effective listing and a risk sharing arrangement was required to mitigate the
risk that people would access the subsidy outside the proposed criteria.
