Fruzaqla FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 13, 2023.
FDA Approved: Yes (First approved November 8, 2023)
Brand name: Fruzaqla
Generic name: fruquintinib
Dosage form: Capsules
Company: Takeda Pharmaceutical Company Limited
Treatment for: Colorectal Cancer
Fruzaqla (fruquintinib) is a highly selective and potent oral inhibitor of VEGFR-1, -2 and -3 for the treatment of previously treated metastatic colorectal cancer.
- Fruzaqla is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.
- Metastatic colorectal cancer is cancer that originated in either the colon or rectum and that has spread to another organ.
- Fruzaqla is an inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3 that works in the treatment of metastatic colorectal cancer by inhibiting VEGF-mediated endothelial cell proliferation and tubular formation.
- FDA approval of Fruzaqla is based on data from the FRESCO (conducted in China) and FRESCO-2 (multi-regional) trials that investigated fruquintinib plus best supportive care versus placebo plus best supportive care in patients with previously treated mCRC.
- In the FRESCO trial, median overall survival was 9.3 months in the fruquintinib group versus 6.6 months in the placebo group.
- In the FRESCO-2 trial, median overall survival was 7.4 months in the fruquintinib group versus 4.8 months in the placebo group. - Fruzaqla capsules are administered orally once daily, with or without food for the first 21 days of each 28-day cycle.
- Warnings and precautions associated with Fruzaqla include hypertension, hemorrhagic events in patients who are at risk for bleeding, infections, gastrointestinal (GI) perforation, hepatotoxicity, proteinuria, palmar-plantar erythrodysesthesia, posterior reversible encephalopathy syndrome (PRES), impaired wound healing, arterial thromboembolic events, allergic reactions to FD&C Yellow No. 5 (tartrazine) and No. 6 (sunset yellow FCF) color additives, and embryo-fetal toxicity.
- Common adverse reactions include hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
Development timeline for Fruzaqla
Further information
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