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Fruquintinib

Clinical data
Trade names	Fruzaqla
Other names	HMPL-013
AHFS/Drugs.com	Monograph
MedlinePlus	a623060
License data	US DailyMed: Fruquintinib
Pregnancy category	AU: D
Routes of administration	By mouth
Drug class	Antineoplastic
ATC code	L01EK04 (WHO)
Legal status
Legal status	AU: S4 (Prescription only) CA: ℞-only US: ℞-only EU: Rx-only
Identifiers
IUPAC name 6--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
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. Fruquintinib is a kinase inhibitor. It is taken by mouth.

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

Fruquintinib was approved for medical use in the United States in November 2023.

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.

History

Efficacy was evaluated in FRESCO-2 (NCT04322539) and FRESCO (NCT02314819). 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. 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.

Society and culture

Legal status

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). The applicant for this medicinal product is Takeda Pharmaceuticals International AG Ireland Branch. Fruzaqla was approved for medical use in the United States in June 2024.

References

1. http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-PI-02658-1
2. "Fruzaqla (Takeda Pharmaceuticals Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 9 December 2024. Retrieved 19 December 2024.
3. "Fruzaqla fruquintinib 1 mg hard capsule bottle (422039)". Therapeutic Goods Administration (TGA). 3 October 2024. Retrieved 19 December 2024.
4. "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-10-18]". Health Canada. 18 October 2024. Retrieved 25 October 2024.
5. "Fruzaqla product information". Health Canada. 11 October 2024. Retrieved 27 December 2024.
6. ^ "Fruzaqla- fruquintinib capsule". DailyMed. 14 November 2023. Archived from the original on 12 December 2023. Retrieved 12 December 2023.
7. ^ "Fruzaqla EPAR". European Medicines Agency. 25 April 2024. Retrieved 27 April 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
8. ^ "Fruzaqla PI". Union Register of medicinal products. 25 June 2024. Retrieved 26 June 2024.
9. ^ "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.
10. "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.
11. Xu X, Yu Y, Liu M, Liang L, Liu T (January 2022). "Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review". Translational Cancer Research. 11 (1): 276–287. doi:10.21037/tcr-20-3539. PMC 8841594. PMID 35261903.
12. Lavacchi D, Roviello G, Guidolin A, Romano S, Venturini J, Caliman E, et al. (March 2023). "Evaluation of Fruquintinib in the Continuum of Care of Patients with Colorectal Cancer". International Journal of Molecular Sciences. 24 (6): 5840. doi:10.3390/ijms24065840. PMC 10051170. PMID 36982913.
13. "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024". European Medicines Agency (Press release). 26 April 2024. Retrieved 13 June 2024.

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

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