3位Ranking of cancer incidence (2020)1
1st | 2nd |
| 4th | 5th | |
Total | Colon | Lung | Stomach | Breast | Prostate |
Male. | Prostate | Colon | Lung | Stomach | Liver. |
Female. | Breast | Colon | Lung | Stomach | Uterus |
3rdOur Japan Oncology Business Division Director, Tom Uchida, stated, "For over 10 years, we have been working on advancing the treatment of mCRC in Japan. Through Frescura, we will be able to contribute even more to the treatment of mCRC in Japan. We will continue to strive to deliver this treatment to colorectal cancer patients and their families who are eagerly awaiting new treatment options."
Here is the English version of the press release
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Fluzacra is an oral inhibitor with selectivity for all three VEGF receptors (1/2/3). VEGFR inhibitors play an extremely important role in inhibiting tumor angiogenesis. Fluzacra is designed to have high selectivity by minimizing off-target kinase activity, enabling sustained target inhibition and offering flexible potential for use as part of combination therapy. The company has an exclusive license for global development, commercialization, and manufacturing of Fulkinib worldwide, excluding mainland China, Hong Kong, and Macau. Fluzacra was approved by the U.S. Food and Drug Administration (FDA) in November 2023, by the European Commission (EC) in June 2024, and by the Ministry of Health, Labour and Welfare in Japan in September 2024. Fulkinib is developed and sold by HUTCHMED in China. Fulkinib was approved for sale by the China National Medical Products Administration (NMPA) in September 2018 and launched in China under the brand name ELUNATE in November 2018.
Product Overview of Fluzacra in Japan
| Product Name | Fluzacra Capsules 1mg/5mg |
| Generic name: | Fulkinib |
| Indications or effects: | Inoperable advanced or recurrent colon and rectal cancer that worsened after chemotherapy for cancer. |
| Usage and dosage: | Generally, in adults, 5 mg of fulquinib once a day is orally administered continuously for 3 weeks, followed by a one-week break. This is repeated as one cycle of administration. The dosage may be reduced according to the patient's condition. |
| Drug price | 1 mg: 5,139.40 yen / 5 mg: 23,866.90 yen |
The FRESCO-2 trial is an international collaborative clinical trial conducted in the USA, Europe, Japan, and Australia, comparing the fulquinib + Best Supportive Care (BSC) group with the placebo + BSC group for patients with metastatic colorectal cancer who have a previous treatment history (NCT04322539). This trial achieved the main evaluation criteria and important secondary endpoints, demonstrating statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) with the administration of fulquinib. The safety profile of fulquinib in the FRESCO-2 trial was consistent with previous trials of fulquinib monotherapy. The results of the trial were presented at ESMO (European Society for Medical Oncology) in September 2022 and subsequently published in The Lancet in June 2023.
Regarding Takeda Pharmaceuticals' efforts in the 'colorectal cancer area' in Japan.
In Japan, colorectal cancer is the most common cancer in terms of incidence, with an estimated forecasted incidence of 0.161 million people and an estimated death toll of 0.054 million people in 2023, according to the cancer statistics from the National Cancer Center. Early-stage colorectal cancer is surgically resectable, but metastatic colorectal cancer still has a poor prognosis with limited treatment options, high unmet needs, and a longing for new treatment options. Our company has been contributing to the treatment of late-stage colorectal cancer patients with limited treatment options and advancements in personalized treatments through innovative pharmaceutical offerings and evidence generation in Japan for over a decade. We will continue to advance efforts for the treatment of colorectal cancer patients and addressing unmet needs.
About Takeda Pharmaceutical
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) aims to contribute to the health of people worldwide and a brighter future. They are working towards innovative pharmaceutical creation in major disease areas and business sectors such as the gastrointestinal, inflammatory diseases, rare diseases, plasma fractionation, oncology (cancer), and neuroscience (neuropsychiatric disorders), as well as vaccines. Collaborating with partners, they are building a strong and diverse pipeline to deliver new treatment options and contribute to improving the quality of life for patients. Based in Japan, Takeda Pharmaceutical is a research and development-oriented biopharmaceutical company rooted in their corporate values of placing patients at the center. Drawing on values shaped over more than two centuries, they operate in approximately 80 countries and regions with the purpose of fulfilling their societal significance. For more details, please visit their website.
In this disclaimer, 'press release' refers to this document, including any oral presentations, Q&A sessions, written or oral materials provided or distributed by Takeda Pharmaceutical Company Limited ('Takeda') in relation to this press release. This press release (including any oral explanations and Q&A sessions related to this press release) does not constitute a part of, and does not constitute an offer to sell or the solicitation of an offer to purchase or subscribe for, any securities, nor a proposal, guidance or solicitation for any purchase, acquisition, sale, disposal or any other transaction in respect thereof. No public offering of securities is made by means of this press release. Unless prepared in accordance with the registration or an exemption from the registration requirements of the U.S. Securities Act of 1933, offers and sales of securities are not being made in the United States. This press release is provided (together with any additional information provided to the recipient) on the condition that it is used by the recipient for information purposes only (and not for consideration of investment, acquisition, disposal or other transactions) and provided that any such use complies with the applicable securities laws. Failure to comply with such restrictions may constitute a violation of the securities laws applicable to such recipient. Companies directly or indirectly owned by Takeda are separate entities. The term 'Takeda' in this press release may, depending on the context, refer only to Takeda Pharmaceutical Company Limited and may be used as a convenient catch-all term for the Takeda group of companies. Similarly, the term 'we,' 'us,' and 'our' may refer to the Takeda group of companies or its employees. These terms may also be used where identifying a specific company is not meaningful or does not serve a useful purpose. The product names mentioned in this press release are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited or their respective owners.
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References
- Original Data: National Cancer Center Cancer Information Service 'Cancer Statistics' (National Cancer Registry)
- Public Interest Incorporated Foundation Cancer Research Promotion Foundation 'Cancer Statistics 2024'
- Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.
- D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.
- Venderbosch, et al. studied the mismatch repair status and BRAF mutation status in patients with metastatic colorectal cancer by conducting a pooled analysis of the Cairo, Cairo2, COIN, and Focus Studies. This research was published in Clinical Cancer Research in 2014; volume 20, issue 20, pages 5322–5330. doi:10.1158/1078-0432.ccr-14-0332.
- Koopman, M., et al. identified a deficient mismatch repair system in patients with sporadic advanced colorectal cancer in their study published in the British Journal of Cancer in 2009; volume 100, issue 2, pages 266–273. doi:10.1038/sj.bjc.6604867.
- Ahcene Djaballah S, et al. discussed the role of HER2 in Colorectal Cancer, highlighting its transformation from a negative predictive factor to a positive actionable target. This study is published in the American Society of Clinical Oncology Educational Book in 2022; pages 1-14. doi:10.1200/EDBK_351354.
- Dasari NA, et al. conducted the FRESCO-2, a global phase 3 multiregional clinical trial (MRCT) to assess the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer. The findings were published in Annals of Oncology in September 2022; volume 33, supplement 7, pages S808-S869. doi:10.1016/annonc/annonc1089.
- Dasari NA, et al. compared Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer in the FRESCO-2 study, an international, multicenter, randomized, double-blind, phase 3 trial. The results were published in The Lancet in 2023; volume 402, issue 10395, pages 41-53. doi:10.1016/S0140-6736(23)00772-9.
