Fruquintinib
Fruquintinib (Fruzaqla, Takeda Pharmaceuticals International AG Ireland) has 1 EU-approved indication in 1 tumour type.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Colorectal cancer1 | |||
None | Monotherapy | 3L+ metastatic | After available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and progressed on or intolerant to either trifluridine-tipiracil or regorafenib |
Full text of section 4.1 (therapeutic indications)
FRUZAQLA as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib.
Label history
4 changes to the Fruzaqla label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes