LONCASTUXIMAB TESIRINE
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Zynlonta®
- Form and strength:
-
- Powder for I.V. infusion 10 mg
- Submission sponsor:
- SWEDISH ORPHAN BIOVITRUM PTY LTD
- Condition/indication:
(therapeutic use) -
- Diffuse large B-cell lymphoma (DLBCL)
- Listing requested:
- Resubmission to request listing of loncastuximab tesirine for the treatment of adult patients with relapsed or refractory DLBCL who have received two or more prior lines of therapy.
- Funding program:
- PBS Section 100 (Efficient Funding Of Chemotherapy)
- Request authority level:
- Authority Required (Telephone/Online) for initial treatment Authority Required (STREAMLINED) for continuing treatment
- PBAC Submission type:
- New PBS listing (Early Re-entry Pathway)
- 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
-
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 the listing of loncastuximab tesirine for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who have received two or more prior lines of therapy.
The PBAC welcomed input from one organisation and also reconsidered the consumer input for loncastuximab tesirine from the March 2026 PBAC meeting. The PBAC again acknowledged the need for therapies for patients unsuitable for, or relapsing after, CAR-T or bispecific therapies.
The PBAC recalled that in March 2026 it had considered that limitations in the submission evidence did not allow confidence about the extent to which loncastuximab tesirine was more effective than chemoimmunotherapy. However, the PBAC had accepted that it was likely reasonable, if uncertain, that loncastuximab tesirine would improve overall survival (the length of time patients remain alive) compared to chemoimmunotherapy. The PBAC had also previously considered it was reasonable to accept that the safety of loncastuximab tesirine was similar to chemoimmunotherapy. After reviewing additional information provided by the sponsor in the resubmission, the PBAC maintained its previous conclusions about the effectiveness and safety of loncastuximab tesirine.
The PBAC previously considered that the claims made by the sponsor about the benefits of loncastuximab tesirine to justify its requested price were too optimistic given the uncertain benefits from the clinical data. The PBAC previously advised that a further price reduction would be required to achieve cost-effectiveness. The PBAC also indicated that a financial arrangement with the sponsor would be appropriate to manage risks that the cost to the PBS of listing loncastuximab tesirine is higher than expected.
The PBAC considered that the price requested by the sponsor in the resubmission was acceptable. The PBAC also considered that the estimates of how many patients may use loncastuximab tesirine and of costs to the PBS presented in the resubmission were reasonable. The PBAC accepted the financial arrangement proposed by the sponsor to manage financial risks associated with listing loncastuximab tesirine on the Pharmaceutical Benefits Scheme.