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Takeda Submits New Drug Application for Fruquintinib

Takeda Submits New Drug Application for Fruquintinib for Previously Treated Metastatic Colorectal Cancer in Japan

CalendarSeptember 29, 2023News Releases

OSAKA, Japan, September 29, 2023 – Takeda (TSE:4502/NYSE:TAK) (“Takeda”) today announced it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for fruquintinib, a selective inhibitor of vascular endothelial growth factor receptor (VEGFR)1, 2 and 3 for the treatment of previously treated metastatic colorectal cancer.

The NDA for fruquintinib is based on the Phase 3 FRESCO-2 global clinical trial conducted in the U.S., Europe, Japan and Australia, as well as the Phase 3 FRESCO clinical trial conducted in China. The FRESCO-2 and FRESCO clinical trials compared fruquintinib plus best supportive care (BSC) with placebo plus BSC in patients with previously treated metastatic CRC. Both trials demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), and progression-free survival (PFS). Fruquintinib was shown to be generally well tolerated by patients.

“Colorectal cancer has the highest incidence and second highest mortality rate among both men and women in Japan1. With these rates consistently increasing each year, the necessity for new treatment options becomes even more evident,” stated Awny Farajallah, M.D., head of Global Medical Affairs Oncology at Takeda. “Following submissions in the U.S and Europe, we are delighted to have submitted the new drug application for fruquintinib to the MHLW, moving one step closer to potentially offering this innovative therapy to patients with advanced disease in Japan.”

The U.S Food and Drug Administration (FDA) granted Priority Review to the new drug application for fruquintinib in May 2023 and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2023. A Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) was validated in June 2023.

Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of China. Fruquintinib is developed and marketed in China by HUTCHMED.

About Fruquintinib

Fruquintinib is a selective oral inhibitor of VEGFR1/2/3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. So far, fruquintinib has been shown to be generally well tolerated in patients.

About FRESCO-2

The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus BSC vs placebo plus BSC in patients with previously treated metastatic CRC. As previously disclosedGo to https://www.hutch-med.com/fresco-2-met-primary-endpoint/, the 691-patient study met its primary endpoint of OS in patients with metastatic CRC who had progressed on standard chemotherapy and relevant biologic agents and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib. In addition to OS, a statistically significant improvement in PFS, a key secondary endpoint, was observed. Fruquintinib has been generally well tolerated in patients to date. Results2,3 from the study were presentedGo to https://www.hutch-med.com/fruquintinib-fresco-2-data-summary-esmo-2022/ at ESMO in September 2022 and subsequently publishedGo to https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/fulltext in The Lancet. Additional details of the study may be found at clinicaltrials.gov, using identifier NCT04322539Go to https://classic.clinicaltrials.gov/ct2/show/NCT04322539.

About CRC

CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer, CRC is the third most prevalent cancer worldwide, associated with more than 935,000 deaths in 2020.4 In the U.S., it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2023.5 In Europe, CRC was the second most common cancer in 2020 with approximately 520,000 new cases and 245,000 deaths. In Japan, CRC was the most common cancer with an estimated 156,000 new cases and 68,000 deaths in 2019.1 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options.

About Takeda

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 https://www.takeda.com.

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  1. Cancer Statistics. Cancer Information Service, National Cancer Center, Japan (Vital Statistics of Japan, Ministry of Health, Labour and Welfare):https://ganjoho.jp/public/qa_links/report/statistics/2023_jp.htmlGo to https://ganjoho.jp/public/qa_links/report/statistics/2023_jp.html

  2. 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.

  3. 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.

  4. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.

  5. Siegel RL, et al. Colorectal cancer statistics, 2023 [published online ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023; 73(3):233-254. doi:10.3322/caac.21772.

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