Takeda Gains Japanese Approval for FRUZAQLA to Treat Advanced Colorectal Cancer

Takeda, a renowned pharmaceutical company, has announced that it has received the green light from Japan's Ministry of Health, Labour and Welfare to produce and market FRUZAQLA Capsules (1mg/5mg). The capsules, also known by their generic name fruquintinib, are a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3. They are designed for the treatment of advanced or recurrent colorectal cancer (CRC) that cannot be cured or surgically removed and has progressed following chemotherapy.

The approval is predominantly based on the findings from the FRESCO-2 trial, a global Phase 3 clinical study conducted in the United States, Europe, Japan, and Australia. This trial evaluated the efficacy of FRUZAQLA combined with the best supportive care (BSC) compared to a placebo combined with BSC in patients with previously treated metastatic colorectal cancer (mCRC). The trial achieved all its primary and key secondary efficacy endpoints, showing consistent benefits for patients administered FRUZAQLA, irrespective of their prior therapies. The safety profile of FRUZAQLA in the trial was manageable, with adverse events leading to discontinuation occurring in 21% of the placebo plus BSC group versus 20% in the FRUZAQLA plus BSC group. The trial results were published in The Lancet in June 2023.

Dr. Takayuki Yoshino, a key figure in the FRESCO-2 study and an expert at the National Cancer Center Hospital East, highlighted the importance of the approval. Despite a decline in colorectal cancer mortality rates due to early detection and improved treatments, the survival rate for metastatic colorectal cancer remains low, necessitating new treatment options. FRUZAQLA’s approval in Japan represents a significant advancement, providing renewed hope for patients, their families, and healthcare professionals involved in the treatment of colorectal cancer.

Teresa Bitetti, president of Takeda’s Global Oncology Business Unit, expressed enthusiasm over the approval, emphasizing Takeda's long-standing commitment to improving treatments for metastatic colorectal cancer in Japan. With FRUZAQLA now approved in various regions, including the U.S. and the European Union, Takeda remains dedicated to extending this treatment to more patients worldwide who are in urgent need of new therapeutic options.

FRUZAQLA functions as a selective oral inhibitor targeting all three VEGFRs, crucial in halting tumor angiogenesis. Its design aims to enhance selectivity, thereby reducing off-target kinase activity while allowing for sustained target inhibition. This feature makes it flexible for potential combination therapies. Takeda holds the exclusive global license to develop, commercialize, and manufacture FRUZAQLA outside mainland China, Hong Kong, and Macau. The U.S. Food and Drug Administration (FDA) approved FRUZAQLA in November 2023, followed by the European Commission (EC) in June 2024. In China, fruquintinib is marketed by HUTCHMED under the brand name ELUNATE, following its approval in September 2018 and market launch in November 2018.

The FRESCO-2 trial, a multi-regional study, was instrumental in securing this approval. Conducted across the U.S., Europe, Japan, and Australia, the trial aimed to assess the efficacy and safety of FRUZAQLA plus BSC compared to placebo plus BSC in patients with refractory mCRC. The study met its primary and key secondary endpoints, demonstrating significant improvements in overall survival and progression-free survival with FRUZAQLA treatment. Its safety profile was consistent with previous studies of fruquintinib.

In Japan, colorectal cancer (CRC) remains the most diagnosed cancer, with an estimated 161,000 new cases and 54,000 deaths in 2023. Although early-stage CRC can be surgically treated, metastatic colorectal cancer (mCRC) presents a significant challenge due to its poor prognosis and limited treatment options. Over the past decade, Takeda has played a crucial role in advancing treatment for late-stage CRC patients, contributing to personalized medicine through innovative therapies and evidence generation. Takeda remains committed to addressing the unmet needs of CRC patients.

Takeda is a values-driven biopharmaceutical company, striving to create better health and a brighter future. Focused on core therapeutic areas such as gastrointestinal and inflammation, rare diseases, and oncology, Takeda aims to deliver transformative treatments through its dynamic and diverse pipeline. With a global presence in about 80 countries, Takeda is dedicated to improving patient experiences and advancing new treatment frontiers.