GlofitamabColumvi
Treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after one or more lines of systemic therapy in patients ineligible for autologous stem cell transplant (ASCT).
Decision on record
- Meeting Jul 2025 Recommended Relapsed/refractory DLBCL after ≥1 line systemic therapy, ASCT/CAR-T ineligible
Access path
- TGA registered · Columvi
TGA label narrower than the PBS population
- Jul 2025Recommended · restricted
vs rituximab in combination with gemcitabine plus oxaliplatin…
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Section 100 Efficient Funding of Chemotherapy, Authority Required (Telephone/Online) listing of glofitamab, in combination with gemcitabine plus oxaliplatin (Glofit-GemOx), for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after one or more lines of systemic therapy and who are unable to receive autologous stem cell transplant (ASCT) or chimeric antigen receptor T-cell (CAR-T) cell …PSD · Jul 2025
The PBAC noted the input from health care professionals, Rare Cancers Australia, Leukaemia Foundation, Lymphoma Australia and the Australasian Leukaemia and Lymphoma group supporting the listing. The PBAC noted the input highlighted the need for additional treatment options for patients who are not suitable for ASCT and ineligible or can’t access CAR-T cell therapy.PSD · Jul 2025
The submission presented a stepped cost-utility analysis comparing Glofit-GemOx versus R-GemOx, informed by efficacy and utility outcomes data from STARGLO. 25PSD · Jul 2025
This was generally appropriate based on the mean age of participants in STARGLO (65 years); however, the mean age of patients with R/R DLBCL in Australian registry data was slightly older at the start of second-line Time horizon 20 years treatment (68 years) and survival was shorter, suggesting a slightly shorter time horizon may be more reasonable for an Australia population.PSD · Jul 2025
The submission described Glofit-GemOx as superior in terms of effectiveness and non- inferior in terms of safety compared to R-GemOx.PSD · Jul 2025
The clinical evidence presented in the submission reasonably supported the claim of superior effectiveness for patients with R/R DLBCL after one or more lines of prior therapy and who are considered transplant ineligible. The STARGLO trial met its’ primary endpoint at the interim analysis demonstrating statistically significant improvements in OS, PFS and CR with Glofit-GemOx compared to R-GemOx.PSD · Jul 2025
The input from Rare Cancers Australia highlighted the impact on individuals of ASCT, CAR-T cell therapy and current chemoimmunotherapy options. The input discussed the benefits of glofitamab for those who are frail and cannot handle the harsh side effects of other treatment options. The input also discussed the side effects of glofitamab and how these will be managed in practice.PSD · Jul 2025
The input from the Leukaemia Foundation discussed current standard of care and emphasised the need for additional treatment options for individuals who are not suitable for ASCT or CAR-T cell therapy. The input also shared comments from individuals living with DLBCL which described the stress associated with the condition and its impact on their quality of life.PSD · Jul 2025
Cost-effectiveness
ICER value not stated in the public summary document text provided.
Decision context
PopulationAdult patients with relapsed or refractory DLBCL after one or more lines of systemic therapy, unsuitable for stem cell transplant, with WHO performance status of 2 or less.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) | — | RCT · OS |
Consumer voice
Healthcare professionals and patient advocacy organisations emphasised the clinical need for glofitamab as an additional treatment option for patients with relapsed/refractory DLBCL who are ineligible for or unable to access ASCT or CAR-T cell therapy. Consumer input highlighted the burden of current treatments, quality of life impacts, and benefits of glofitamab for frail patients, while noting m
The health care professionals also noted the risk of CRS identified in the trial and described this as manageable but acknowledged there was an additional burden of care due to the need to remain in the care setting for an extended duration on the day of treatment. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to second-line (after one or more prior lines) and adds WHO performance status ≤2 requirement; TGA label does not specify these.