− If Approved in the European Union, Fruquintinib Will Be the First Novel Targeted Therapy for Metastatic Colorectal Cancer Regardless of Biomarker Status in Over a Decade
− Positive Opinion Based on Results from a Phase 3 Clinical Trial Which Demonstrated Significant Improvements in Overall Survival and Progression Free Survival versus Placebo Plus Best Supportive Care, with Benefit Seen Regardless of Prior Types of Therapy Received
OSAKA, Japan & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.1,2
“People living with metastatic colorectal cancer in the European Union currently have limited treatment options, which can lead to poor outcomes. With this positive opinion for fruquintinib, we are one step closer to potentially offering patients a new, oral, chemotherapy-free option that may provide a survival benefit,” said Awny Farajallah, M.D., chief medical officer, oncology at Takeda. “We look forward to the European Commission’s official decision in the near future as we work to redefine the treatment landscape and help address a significant unmet need for those affected by mCRC.”
The Committee’s positive opinion was primarily based on results from the Phase 3 multi-regional FRESCO-2 trial. The trial investigated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC. FRESCO-2 met all its primary and key secondary efficacy endpoints and showed consistent benefit among patients treated with fruquintinib, regardless of the prior types of therapies they received. Fruquintinib demonstrated a manageable safety profile in FRESCO-2. Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with fruquintinib plus BSC versus 21% of those treated with placebo plus BSC. Data from FRESCO-2 were published in The Lancet in June 2023.3
About Fruquintinib
Fruquintinib is a selective oral inhibitor of VEGFR -1, -2 and -3. VEGFR inhibitors play a pivotal role in blocking 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 potential use as part of combination therapy.
Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. Fruquintinib was approved by the U.S. Food and Drug Administration (FDA) in November 2023 and is marketed under the brand name FRUZAQLA®. A submission to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) took place in September 2023. Fruquintinib is developed and marketed in China by HUTCHMED. Fruquintinib was approved for marketing by the China National Medical Products Administration (NMPA) in September 2018 and commercially launched in China in November 2018 under the brand name ELUNATE®.
U.S. IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥20%) following treatment with FRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot skin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.
DRUG INTERACTIONS: Avoid concomitant administration of FRUZAQLA with strong or moderate CYP3A inducers.
USE IN SPECIFIC POPULATIONS
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see FRUZAQLA (fruquintinib) full Prescribing Information
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. In Europe, CRC was the second most common cancer in 2020, with approximately 520,000 new cases and 245,000 deaths.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 2024.5 In Japan, CRC was the most common cancer, with an estimated 148,000 new cases and 60,000 deaths, in 2020.4 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.6,7,8,9,10
About the Phase 3 FRESCO-2 Trial
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 mCRC (NCT04322539). The study met all its primary and key secondary endpoints, demonstrating that treatment with fruquintinib resulted in statistically significant and clinically meaningful improvement in OS and PFS. The safety profile of fruquintinib in FRESCO-2 was consistent with previously reported fruquintinib studies. Results from the study were presented at ESMO in September 2022 and subsequently published in The Lancet in June 2023.11,3
The Phase 3 FRESCO-2 trial supported the marketing authorization application (MAA) from the EMA for fruquintinib, which was validated and accepted for review in June 2023.
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 www.takeda.com.
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Medical Information
This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.
References:
Contacts
Media:
Japanese Media
Jun Saito
jun.saito@takeda.com
U.S. and International Media
Emma Nash
emma.nash@takeda.com
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