Fruzaqla (fruquintinib)
- Region
- 🇪🇺 EU
- Active substance
- fruquintinib
- Company
- Takeda Pharmaceuticals International AG Ireland
- Status
- Authorised
- Therapeutic area
- Colorectal Neoplasms
- CHMP opinion
- Thu 25 Apr 2024
- EU approval
- Thu 20 Jun 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005979
- ATC
- L01EK
- Official record
- www.ema.europa.eu
Indication
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.