Takeda Gains EU Approval for FRUZAQLA in Treated Metastatic Colorectal Cancer

Takeda Pharmaceuticals has announced that the European Commission (EC) has approved FRUZAQLA (fruquintinib) as a monotherapy for adult patients with metastatic colorectal cancer (mCRC). This approval is significant as it marks the first novel targeted therapy in the European Union for mCRC in over a decade, irrespective of biomarker status. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and a prior approval by the U.S. Food and Drug Administration (FDA) in November 2023.

The approval is based on the successful results from the Phase 3 FRESCO-2 trial. This multi-regional trial evaluated the efficacy of FRUZAQLA in combination with best supportive care (BSC) compared to a placebo plus BSC in patients who had previously received standard treatments for mCRC. The study met all its primary and key secondary endpoints, demonstrating significant benefits in patients treated with FRUZAQLA. The safety profile was manageable, with adverse reactions leading to treatment discontinuation occurring in 20% of patients treated with FRUZAQLA compared to 21% in the placebo group. The findings were published in The Lancet in June 2023.

Josep Tabernero, MD, PhD, director of the Vall d´Hebron Institute of Oncology (VHIO), highlighted the importance of this approval for patients struggling with the adversities of mCRC and the side effects of existing treatments. He emphasized the need for innovative treatments like fruquintinib, which is an oral, chemotherapy-free targeted agent.

Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, noted that this approval offers a new treatment option for patients with previously treated mCRC, regardless of whether their tumors have actionable mutations. She expressed optimism about offering a treatment that has a manageable safety profile and can be effective regardless of previous therapies.

FRUZAQLA is a selective oral inhibitor of all three VEGF receptors. VEGFR inhibitors are crucial in blocking tumor angiogenesis. FRUZAQLA was designed to limit off-target kinase activity, ensuring high drug exposure and sustained target inhibition, which makes it suitable for potential combination therapy.

Takeda holds the exclusive worldwide rights to develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong, and Macau. In China, Fruquintinib is marketed by HUTCHMED under the brand name ELUNATE and was approved by the China National Medical Products Administration in September 2018.

Colorectal cancer (CRC) starts in the colon or rectum and is the third most prevalent cancer globally. In 2022, CRC was responsible for more than 1.9 million new cases and 900,000 deaths worldwide. In Europe, CRC was the second most common cancer, with around 538,000 new cases and 248,000 deaths. The U.S. is expected to see 153,000 new CRC cases and 53,000 deaths in 2024, while Japan recorded over 145,000 new cases and 60,000 deaths in 2022.

Despite surgical resection being an option for early-stage CRC, metastatic CRC presents significant challenges with limited treatment options. While some patients benefit from personalized therapies based on molecular characteristics, many tumors lack actionable mutations.

The FRESCO-2 trial, conducted in the U.S., Europe, Japan, and Australia, was a pivotal study that confirmed the efficacy and safety of FRUZAQLA. The study results were presented at ESMO in September 2022 and later published in The Lancet.

Takeda is committed to improving patient health and advancing treatment options through its diverse pipeline. As a leading biopharmaceutical company, Takeda aims to create life-transforming treatments in its core areas, including oncology and gastrointestinal diseases, driven by values that have guided the company for over two centuries.