Contents

Fruquintinib

Fruquintinib

Clinical data
Trade names	Fruzaqla
Other names	HMPL-013
License data	US DailyMed: Fruquintinib
Routes of administration	By mouth
Drug class	Antineoplastic
ATC code	L01EK04 (WHO)
Legal status
Legal status	US: ℞-only[1] EU: Rx-only[2][3]
Identifiers
IUPAC name 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]-N,2-dimethyl-1-benzofuran-3-carboxamide
CAS Number	1194506-26-7
PubChem CID	44480399
IUPHAR/BPS	9428
DrugBank	DB11679
ChemSpider	39625837
UNII	49DXG3M5ZW
KEGG	D11977
ChEBI	CHEBI:229221
ChEMBL	ChEMBL4303214
Chemical and physical data
Formula	C21H19N3O5
Molar mass	393.399 g·mol−1
3D model (JSmol)	Interactive image
SMILES CNC(=O)C1=C(C)OC2=CC(OC3=NC=NC4=CC(OC)=C(OC)C=C34)=CC=C12
InChI InChI=1S/C21H19N3O5/c1-11-19(20(25)22-2)13-6-5-12(7-16(13)28-11)29-21-14-8-17(26-3)18(27-4)9-15(14)23-10-24-21/h5-10H,1-4H3,(H,22,25) Key:BALLNEJQLSTPIO-UHFFFAOYSA-N

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] It is taken by mouth.^[1]

The most common adverse reactions include hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.^[4]

Fruquintinib was approved for medical use in the United States in November 2023.^[4][5]

Medical uses[edit]

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][4][6][7]

History[edit]

Efficacy was evaluated in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819).^[4] 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.^[4] 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.^[4]

Society and culture[edit]

Legal status[edit]

In April 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Fruzaqla, intended for the treatment of people with previously treated metastatic colorectal cancer (mCRC).^[2][8] The applicant for this medicinal product is Takeda Pharmaceuticals International AG Ireland Branch.^[2] Fruzaqla was approved for medical use in the United States in June 2024.^[3]

References[edit]

^ ^{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.

External links[edit]

• 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

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