Takeda's FRUZAQLA™ (fruquintinib) publicly reimbursed in Quebec for the treatment of metastatic colorectal cancer (mCRC)

TORONTO, Aug. 28, 2025 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that FRUZAQLA^TM (fruquintinib capsules) will now be reimbursed by Régie de l'assurance maladie (RAMQ) for people in Quebec, under certain criteria, as a treatment for adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates, for available standard therapies.¹

FRUZAQLA received market authorization by Health Canada in September 2024, followed by positive reimbursement recommendations by Canada's Drug Agency (CDA-AMC) and Institut national d'excellence en santé et services sociaux (INESSS).

"We are pleased to see Quebec reimbursing this new treatment to benefit people in the province living with this terminal cancer," said Filomena Servidio-Italiano, President & CEO, Colorectal Cancer Resource & Action Network. "The majority of deaths occur among those diagnosed with colorectal cancer in the metastatic setting. Having a treatment that supports people at the metastatic phase of the disease is crucial, for it can help these individuals achieve potential improved outcomes, including survival and quality of life."

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.² In 2024, over 25,000 people were diagnosed with colorectal cancer (CRC) in Canada with over 9,000 dying from the disease.³ Approximately 70 per cent of patients with CRC will experience metastatic disease, whether at diagnosis or after treatment with metastases being the main cause of CRC-related death.^4,5

FRUZAQLA will be reimbursed under the RAMQ public formulary within the following criteria: As a monotherapy, for treatment of metastatic colorectal cancer in persons with an ECOG performance status of zero or 1 and for whom the following therapies have failed, unless there is a contraindication or a serious intolerance:

• Chemotherapy based on irinotecan and a fluoropyrimidine
• Chemotherapy based on oxaliplatin and a fluoropyrimidine
• A treatment including bevacizumab
• In the presence of a non-mutated RAS gene, a treatment including panitumumab or cetuximab
• A treatment including trifluridine/tipiracil association

"The reimbursement of FRUZAQLA in Quebec is a first step to increasing access to this treatment for people across Canada living with metastatic colorectal cancer," said Kiran Dharani, Oncology Country Head, Takeda Canada. "At Takeda, we are committed to developing innovative oncology therapies and working with provinces to improve access so those affected can benefit from the newest treatments available."

About FRUZAQLA^TM
FRUZAQLA (fruquintinib) is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking tumor angiogenesis.⁶ FRUZAQLA works by helping to stop tumors from making new blood vessels and therefore slowing down the growth of cancer.⁷

The approval of FRUZAQLA for the treatment of metastatic colorectal cancer is based on data from two large Phase 3 trials: the multi-regional FRESCO-2 trial, data from which were published in The Lancet, along with the FRESCO trial conducted in China, data from which were published in JAMA. In both trials, FRUZAQLA plus best supportive care demonstrated significant improvements in overall survival, with corresponding improvements in progression free survival, versus placebo plus best supportive care.^8,9

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/ .

¹ FRUZAQLATM (fruquintinib capsules), Submission Control 275803, Product Monograph, Takeda Canada Inc. (SEP 10, 2024). Available at: https://takeda.info/en-ca-fruzaqlapm
² Canadian 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
³ Canadian Cancer Society. Colorectal Cancer Statistics. 2024. Available at: https://cancer.ca/en/cancer-information/cancer-types/colorectal/statistics
⁴ Atreya 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
⁵ Vatandoust S, et al. World J Gastroenterol. 2015;21(41):11767-76.
⁶ FRUZAQLATM (fruquintinib capsules), Submission Control 275803, Product Monograph, Takeda Canada Inc. (SEP 10, 2024). Available at: https://takeda.info/en-ca-fruzaqlapm
⁷ FRUZAQLATM (fruquintinib capsules), Submission Control 275803, Product Monograph, Takeda Canada Inc. (SEP 10, 2024). Available at: https://takeda.info/en-ca-fruzaqlapm
⁸ Dasari 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.
⁹ Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study [published online ahead of print, 2023 Jun 15]. Lancet. 2023. DOI: 10.1016/S0140-6736(23)00772-9.

SOURCE Takeda Canada Inc.

Media Contacts: Kristen King, [email protected], 905-876-6402