PazopanibPazopanib ADVZ
Initial and continuing treatment of advanced (unresectable and/or metastatic) soft tissue sarcoma in patients who have received prior chemotherapy including anthracycline and have WHO performance status of 2 or less.
Decisions on record
- Meeting Jul 2013 Recommended Cancer in soft tissue
- Meeting Nov 2012 Not recommended Cancer in soft tissue no PSD
- Meeting Mar 2012 Recommended Anti-cancer drug
- Meeting Jul 2010 Not recommended Anti-cancer drug
Access path
- TGA registered · Pazopanib ADVZ
TGA label narrower than the PBS population
- Jul 2010Not recommended
clinically inappropriate PBS restriction, significant uncertainty regarding non-inferiority to sunitinib, indirect…
- Jul 2010Not recommended
Clinically inappropriate restriction that does not reflect actual treatment algorithm; non-inferiority to sunitinib not…
- 2012Not recommended
claim for superior efficacy in terms of overall survival is not adequately supported, modelled OS advantage unlikely to…
- ↻ resubmittedMar 2012Recommended · restricted
Comparator changed: best supportive care → sunitinib
- Mar 2012Recommended · restricted
Comparator changed: best supportive care → sunitinib
- Jul 2013Recommended
Comparator changed: sunitinib → 50% best supportive care and 50% ifosfamide/MESNA
- PBS listing · Authority Required
Cost-effectiveness
Although the PBAC noted the unclear, potentially high ICER of pazopanib (due to the indeterminate ratio of the comparator in a practical setting), and the unsupported claim for superior efficacy for OS, the PBAC accepted the submission based on PFS benefit in the context of high unmet clinical need in a population that has limited treatment options and the modest overall cost to the Commonwealth. PBAC · 2013
Decision context
PopulationAdults with advanced (unresectable and/or metastatic) soft tissue sarcoma who have received prior chemotherapy including anthracycline, with WHO performance status 0–2, and no prior angiogenesis inhibitor treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended | 50% best supportive care and 50% ifosfamide/MESNA | $45k–75k | RCT · PFS |
| Mar 2012 | Recommended · restricted | sunitinib | — | RCT · PFS |
| Mar 2012 | Recommended · restricted | sunitinib | — | RCT · PFS |
| 2012 | Not recommended | best supportive care | $45k–75k | RCT · PFS |
| Jul 2010 | Not recommended | sunitinib | — | RCT · PFS |
| Jul 2010 | Not recommended | sunitinib | — | RCT · PFS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| VEG110727 (PALETTE) | Ph 3 | 369 | Progression-free Survival (PFS) | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status 0–2 and no prior angiogenesis inhibitor treatment; TGA label has no such restrictions.