Fruquintinib
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Trade names | Fruzaqla |
Other names | HMPL-013 |
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Routes of administration | By mouth |
Drug class | Antineoplastic |
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Formula | C21H19N3O5 |
Molar mass | 393.399 g·mol−1 |
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Fruquintinib, sold under the brand name Fruzaqla, is an anti-cancer medication used for the treatment of colorectal cancer.[1] Fruquintinib is a kinase inhibitor.[1]
The most common adverse reactions include hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.[2]
Fruquintinib was approved for medical use in the United States in November 2023.[2][3]
Medical uses
Fruquintinib is indicated for adults with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.[1][2]
History
Efficacy was evaluated in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819).[2] FRESCO-2 (NCT04322539), an international, multicenter, randomized, double-blind, placebo-controlled trial, evaluated 691 participants with metastatic colorectal cancer who had disease progression during or after prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, an anti-VEGF biological therapy an anti-EGFR biological therapy if RAS wild type, and at least one of trifluridine/tipiracil or regorafenib.[2] FRESCO, a multicenter, placebo-controlled trial conducted in China, evaluated 416 participants with metastatic colorectal cancer who had disease progression during or after prior fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy.[2]
References
- ^ a b c d "Archived copy" (PDF). Archived (PDF) from the original on 10 November 2023. Retrieved 10 November 2023.
{{cite web}}
: CS1 maint: archived copy as title (link) - ^ a b c d e f "FDA approves fruquintinib in refractory metastatic colorectal cancer". U.S. Food and Drug Administration (FDA). 8 November 2023. Archived from the original on 10 November 2023. Retrieved 10 November 2023. This article incorporates text from this source, which is in the public domain.
- ^ "Takeda Receives U.S. FDA Approval of Fruzaqla (fruquintinib) for Previously Treated Metastatic Colorectal Cancer" (Press release). Takeda. 8 November 2023. Archived from the original on 8 November 2023. Retrieved 10 November 2023 – via Business Wire.
External links
- Clinical trial number NCT04322539 for "A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer (FRESCO-2)" at ClinicalTrials.gov
- Clinical trial number NCT02314819 for "A Phase III Trial Evaluating Fruquintinib Efficacy and Safety in 3+ Line Colorectal Cancer participants (FRESCO) (FRESCO)" at ClinicalTrials.gov