Fruquintinib

Edit links
Source: Wikipedia, the free encyclopedia.

Fruquintinib
Clinical data
Trade namesFruzaqla
Other namesHMPL-013
License data
Antineoplastic
ATC code
Legal status
Legal status
Identifiers
  • 6-[(6,7-dimethoxyquinazolin-4-yl)oxy]-N,2-dimethyl-1-benzofuran-3-carboxamide
JSmol)
  • CNC(=O)C1=C(C)OC2=CC(OC3=NC=NC4=CC(OC)=C(OC)C=C34)=CC=C12
  • 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

by mouth.[1]

The most common adverse reactions include

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][4][5]

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]

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).[6] The applicant for this medicinal product is Takeda Pharmaceuticals International AG Ireland Branch.[6]

References

  1. ^ a b c d e "Fruzaqla- fruquintinib capsule". DailyMed. 14 November 2023. Archived from the original on 12 December 2023. Retrieved 12 December 2023.
  2. ^ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ "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.
  4. PMID 35261903
    .
  5. PMID 36982913
    .
  6. ^ a b "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.

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
Retrieved from "https://en.wikipedia.org/w/index.php?title=Fruquintinib&oldid=1220979869"