FruquintinibFruzaqla
Treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy.
Decisions on record
- Meeting Sep 2024 Recommended Metastatic colorectal cancer (mCRC) — previously treated or not candidates for available therapies
- Meeting Jul 2024 Deferred Metastatic colorectal cancer no PSD
Access path
- TGA registered · Fruzaqla
TGA label narrower than the PBS population
- Sep 2024Recommended · restricted
vs trifluridine/tipiracil (TRI/TIP)
- PBS listing · Authority Required
From the public summary
The PBAC recommended the Authority Required (STREAMLINED) listing for fruquintinib for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with or who are not considered candidates for fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy. Listing was recommended on a cost-minimisation basis against trifluridine/tipiracil (TRI/TIP).PSD · Sep 2024
The PBAC considered that fruquintinib 5 mg/day for 21 days of each 28-day cycle (total 105 mg) is equi-effective to TRI/TIP 60 mg twice daily on days 1-5 and 8-12 of each 28- day cycle (total 1,200 mg).PSD · Sep 2024
The submission presented a CMA of fruquintinib versus TRI/TIP based on the claim of non-inferior efficacy and safety. The CMA presented was based on the published price for TRI/TIP. The evaluation noted that the CMA is only appropriate if the following are 22PSD · Sep 2024
The PBAC considered that fruquintinib 5 mg/day for 21 days of each 28-day cycle (total 105 mg) is equi-effective to TRI/TIP 60 mg twice daily on days 1-5 and 8-12 of each 28- day cycle (total 1,200 mg).PSD · Sep 2024
The submission described fruquintinib as non-inferior in terms of effectiveness compared to TRI/TIP. This claim may be supported by the evidence provided in the submission within the confines of the defined comparison (fruquintinib versus TRI/TIP in patients who have received at least two prior therapies for mCRC), but the following uncertainties remain:PSD · Sep 2024
• Clinical evidence from FRESCO 1 supports the 3L use of fruquintinib as an alternative to TRI/TIP; however, the trial only enrolled Chinese patients. Given the population in FRESCO 2 was pre-treated with TRI/TIP, the clinical evidence presented from FRESCO 2 is more relevant to inform decision-making regarding 21PSD · Sep 2024
Comments from 2 health care professionals described the lack of effective later-line treatment options for patients with mCRC and noted the potential for fruquintinib in addressing this gap. One respondent noted their patient is responding well to fruquintinib treatment.PSD · Sep 2024
Bowel Cancer Australia stated that fruquintinib could benefit up to 800 Australians with metastatic bowel cancer each year by improving median overall survival and noted that the oral formulation made the treatment accessible and manageable for many patients. Rare Cancers Australia stated that the PBS listing of fruquintinib would significantly reduce the financial burden of patients having to self-fund this treatment.PSD · Sep 2024
Cost-effectiveness
Cost-minimisation analysis approach; no ICER calculated by design.
Decision context
PopulationAdult patients with metastatic colorectal cancer who have been previously treated with or are not considered candidates for fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and an anti-EGFR therapy, with WHO performance status of 1 or less.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2024 | Recommended · restricted | trifluridine/tipiracil (TRI/TIP) | — | RCT · OS |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| FRESCO 1 | Ph 3 | 416 | overall survival | completed |
Consumer voice
Five stakeholders (2 healthcare professionals and 3 organisations) provided supportive comments on fruquintinib for metastatic colorectal cancer, highlighting the lack of effective later-line treatment options, potential survival benefits, improved accessibility through oral formulation, and reduced financial burden for patients.
Comments from 2 health care professionals described the lack of effective later-line treatment options for patients with mCRC and noted the potential for fruquintinib in addressing this gap. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO performance status ≤1, which is not mentioned in the TGA-registered indication.