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FRUZAQLA(TM) (fruquintinib capsules) now reimbursed in Ontario to treat metastatic colorectal cancer (mCRC)

Key Takeaway: Takeda Canada has announced that Fruzaqla (fruquintinib capsules) is now included in Ontario's Exceptional Access Program for reimbursement. This treatment is aimed at adult patients with metastatic colorectal cancer (mCRC) who have not responded to standard therapies. The authorization follows positive results from Phase 3 trials demonstrating improved survival rates. Takeda is committed to ensuring access for all eligible patients across Canada.
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POSITIVE FACTORS

  • FRUZAQLA is now reimbursed in Ontario, expanding access for patients.
  • The treatment offers hope for patients with mCRC resistant to standard therapies.
  • Positive clinical trial results support its efficacy in improving survival rates.

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Full Press Release Details

TORONTO,Feb. 2, 2026/CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that Ontario Drug Benefit (ODB) include FruzaqlaTM(fruquintinib capsules) in the list of drugs eligible for funding through the Exceptional Access Program (EAP) for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for available standard therapies.1This treatment is eligible for reimbursement if specific clinical criteria are met.
"When patients with metastatic colorectal cancer become resistant to all currently funded therapies in their province, many will face a grim future as on average, half of these patients do not survive for more than five months," said Dr. Eric Chen, Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre. "FRUZAQLA gives those living with mCRC an important new treatment option to potentially give them more time to spend with their family and enjoy other life milestones."
mCRC refers to cancer of the colon that has spread to other parts of the body (called distant metastasis), such as to the liver or lungs.2Colorectal cancer is the third most diagnosed cancer in Ontario with an estimated Approximately 70percent of patients with CRC will experience metastatic disease, whether at diagnosis or after treatment with metastases being the main cause of CRC-related death.3,4
Ontario is the latest province to reimburse FRUZAQLA following Quebec, British Columbia, New Brunswick, Nova Scotia and Saskatchewan. FRUZAQLA received market authorization by Health Canada in September 2024 and has received a positive reimbursement recommendation by Canada's Drug Agency (CDA-AMC) and Institut national d'excellence en santé et services sociaux (INESSS).
"We're pleased that more Canadians living with mCRC now have access to FRUZAQLA, including those in Ontario, the province with the highest number of patients," said Kiran Dharani, Oncology Country Head, Takeda Canada. "We remain committed to working with provinces to ensure every patient who can benefit from this treatment has the opportunity to do so."
About FRUZAQLATMFRUZAQLATM(fruquintinib capsules) is a selective oral inhibitor of vascular endothelial growth factors receptors (VEGFR) -1, -2, and-3 with half maximal inhibitory concentration (IC50) values of 33, 35, and0.5nM, respectively. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis.5FRUZAQLATMworks by helping to stop tumors from making new blood vessels and therefore slowing down the growth of cancer.1
The authorization for the treatment of metastatic colorectal cancer is based on data from two large Phase3 trials: the multi-regional FRESCO-2 trial, data from which werepublishedinTheLancet, along with the FRESCO trial conducted in China, data from which werepublishedinJAMA. In both trials, FRUZAQLATMplus best supportive care demonstrated significant improvements in overall survival, with corresponding improvements in progression free survival, versus placebo plus best supportive care.6,7
About Takeda Canada Inc.Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit:https://www.takeda.com/en-ca/.
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1FRUZAQLATM(fruquintinib capsules), Product Monograph, Takeda Canada Inc. (SEP 10, 2024). Available at:https://takeda.info/en-ca-fruzaqlapm
2Canadian Cancer Society. Stages of colorectal cancer. 2025. Available at:https://cancer.ca/en/cancer-information/cancer-types/colorectal/staging#:~:text=For%20stage%202C%2C%20the%20tumour,peritoneum
3Atreya CE, Yaeger R, Chu E. Systemic therapy for metastatic colorectal cancer: from current standards to future molecular targeted approaches. Am Soc Clin Oncol Educ Book. 2017;37:246-256. doi:10.1200/EDBK_175679
4Vatandoust S, et al. World J Gastroenterol. 2015;21(41):11767-76.
5Zhang Y, Zou JY, Wang Z, Wang Y. Fruquintinib: a novel antivascular endothelial growth factor receptor tyrosine kinase inhibitor for the treatment of metastatic colorectal cancer. Cancer Manag Res. 2019 Aug 16;11:7787-7803. doi: 10.2147/CMAR.S215533. PMID: 31496821; PMCID: PMC6701622. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC6701622/
6Dasari NA, et al. LBA25 – FRESCO-2: A global phase 3 multiregional clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. Ann Oncol. 2022 Sep;33(suppl_7): S808-S869. Doi:10.1016/annonc/annonc1089.
7Li J, Qin S, Xu R, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486–2496. doi:10.1001/jama.2018.7855

Frequently Asked Questions

What is FRUZAQLA used for?

FRUZAQLA is used to treat metastatic colorectal cancer in patients who have not responded to standard therapies.

Who is eligible for FRUZAQLA reimbursement in Ontario?

Adult patients with metastatic colorectal cancer who meet specific clinical criteria are eligible.

What were the results of the clinical trials for FRUZAQLA?

Clinical trials showed that FRUZAQLA significantly improved overall survival and progression-free survival.

Which provinces have approved FRUZAQLA reimbursement?

FRUZAQLA is reimbursed in Ontario, Quebec, British Columbia, New Brunswick, Nova Scotia, and Saskatchewan.

Last updated: Feb 2, 2026