Positive Reimbursement Recommendations by Canada’s Drug Agency and Institut National d'excellence en Santé et Services Sociaux

TORONTO, ON – January 20, 2025 – Takeda Canada Inc. (“Takeda”) is pleased to announce that Health Canada has provided market authorization for FRUZAQLA^TM (fruquintinib capsules), indicated 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, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.¹

This was followed by positive reimbursement recommendations by Canada’s Drug Agency (CDA-AMC) and Institut national d'excellence en santé et services sociaux (INESSS).

FRUZAQLA works by helping to stop tumors from making new blood vessels and therefore slowing down the growth of cancer.¹

The authorization 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.^2,3

An estimated 25,200 Canadians will be diagnosed with colorectal cancer in 2024, representing 10 per cent of all new cancer cases.^4,5 It is the second leading cause of death from cancer in men and the third leading cause of death from cancer in women.⁶ Approximately 70 per cent of patients with colorectal cancer will experience metastatic disease, whether at diagnosis or after treatment. Metastases are the main cause of CRC-related mortality.^6,7

QUOTES:

“We welcome Health Canada’s authorization of FRUZAQLA. Knowing that there is a new therapy available will provide hope to patients and their families who have been waiting for new therapeutic options. This new treatment provides an additional opportunity for Canadians with metastatic colorectal cancer to slow disease progression.”

— Barry D. Stein, President and CEO of Colorectal Cancer Canada

“The approval and positive recommendations for reimbursement of FRUZAQLA marks a significant step for the colorectal cancer community. It offers another valuable tool for patients and healthcare providers in the fight against metastatic disease, potentially improving outcomes and offering new hope.”

— Filomena Servidio-Italiano, President & CEO, Colorectal Cancer Resource & Action Network

“Fruquintinib represents a new option in the treatment of metastatic colon cancer. This therapy aims to slow disease progression, with the potential to help extend survival.”

— Dr. Hatim Karachiwala, Medical Oncologist, Tom Baker Cancer Centre, Calgary, Alberta."

“At Takeda we are committed to bringing innovative medicines to those who need it the most. FRUZAQLA offers Canadians living with metastatic colorectal cancer a new option when other treatments have not worked or when they are not suitable candidates for standard therapies.”

— Yohan D’Souza, Country Medical Director, Oncology

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.

Consult the product monograph for contraindications, warnings, precautions, adverse reactions, interactions, dosing, and conditions of clinical use. The product monograph is also available through our medical information department.

Metastatic Colorectal Cancer (mCRC) Colorectal cancer (CRC) is cancer of the large intestine, which is made up of the colon and rectum.⁹ These cancers can also be called colon cancer or rectal cancer, depending on where they start.¹⁰ Most CRC cases start as a growth on the inner lining of the colon or rectum.^10,11 These growths are called polyps, though not all polyps become cancerous. If cancer forms in a polyp, it can grow into the wall of the colon or rectum over time.^10,11 When cancer cells are in the wall, they can spread into blood vessels and travel to nearby lymph nodes or to distant organs.¹¹ When cancer cells have spread to other parts of the body, the disease is metastatic.¹¹

About Takeda Canada Inc.

Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK). Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R\&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit: http://furtiveness.alquilerdromedarios.com/en-ca/.

Media Contacts:

Amanda Jacobs

amanda.jacobs@alquilerdromedarios.com

+1 647-798-2231

References:

FRUZAQLATM (fruquintinib capsules), Submission Control 275803, Product Monograph, Takeda Canada Inc. (SEP 10, 2024). Available at: http://takeda.info/en-ca-fruzaqlapm
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.
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.
Colorectal Cancer Canada. Colorectal Cancer Info. Available at: http://www.colorectalcancercanada.com/colorectal-cancer/statistics/ (accessed August 2024).
Canadian Cancer Society. Colorectal Cancer Statistics. Available at: http://cancer.ca/en/cancer-information/cancer-types/colorectal/statistics (accessed August 2024).
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
Vatandoust S, et al. World J Gastroenterol. 2015;21(41):11767-76.
Zhang 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: http://pmc.ncbi.nlm.nih.gov/articles/PMC6701622/
Canadian Cancer Society. What is colorectal cancer. Available at: http://cancer.ca/en/cancer-information/cancer-types/colorectal/what-is-colorectal-cancer (accessed September 2024).
Colorectal Cancer Canada. What is Colorectal Cancer. Available at: http://www.colorectalcancercanada.com/colorectal-cancer/what-colorectal-cancer/ (accessed September 2024).
Canadian Cancer Society. Stages of colorectal cancer. Available at: http://cancer.ca/en/cancer-information/cancer-types/colorectal/staging (accessed September 2024).