TARLATAMAB

Information current as at: 1 November 2026

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

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

PBAC Recommendation:

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.

Public Summary Document:
Not yet available

Case ID
a1319
Page last updated
31 October 2026
v.9.20