Takeda Receives Positive CHMP Opinion For Fruquintinib In Previously Treated Metastatic Colorectal Cancer
Takeda Receives Positive CHMP Opinion For Fruquintinib In Previously Treated Metastatic Colorectal Cancer
− 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
− 如果獲得歐盟批准，呋喹替尼將成爲十多年來首款治療轉移性結直腸癌的新型靶向療法，無論生物標誌物地位如何
− 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
− 正面評價基於一項3期臨床試驗的結果，該試驗表明，與安慰劑加上最佳支持性治療相比，總體存活率和無進展存活率均有顯著改善，無論先前接受哪種類型的治療，均可獲得益處
Takeda ((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
武田（TAK）今天宣佈，歐洲藥品管理局（EMA）人用藥品委員會（CHMP）已建議批准呋喹替尼，這是一種血管內皮生長因子受體（VEGFR）-1、-2和-3的選擇性抑制劑，用於治療先前接受過治療的轉移性結直腸癌（mCRC）的成年患者。歐盟委員會（EC）在確定用於mCRC的呋喹替尼在整個歐盟（EU）、挪威、列支敦士登和冰島的潛在上市許可時，將考慮CHMP的積極意見。如果獲得批准，呋喹替尼將成爲歐盟批准用於先前治療的mcrc.1,2的所有三種血管內皮生長因子受體中的第一種也是唯一的選擇性抑制劑
"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."
“在歐盟，轉移性結直腸癌患者目前的治療選擇有限，這可能導致預後不佳。武田腫瘤學首席醫學官Awny Farajallah醫學博士說，有了對呋喹替尼的這種積極評價，我們離可能爲患者提供一種新的口服、無需化療的選擇又近了一步，這可能帶來生存益處。“我們期待歐盟委員會在不久的將來做出正式決定，我們將努力重新定義治療格局，並幫助解決受mCRC影響者的大量未滿足的需求。”
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
委員會的積極意見主要基於 3 期多區域 FRESCO-2 試驗的結果。該試驗調查了在先前接受過mCRC治療的患者中呋喹替尼加最佳支持治療（BSC）與安慰劑加BSC的對比。FRESCO-2 達到了其所有主要和關鍵次要療效終點，無論之前接受過哪種療法，在接受呋喹替尼治療的患者中均顯示出持續的益處。呋喹替尼在 FRESCO-2 中表現出可控的安全性。在接受呋喹替尼加BSC治療的患者中，有20％出現導致停止治療的不良反應，而使用安慰劑加BSC治療的患者中，這一比例爲21％。來自 FRESCO-2 的數據發佈於 《柳葉刀》 於 2023.3 年 6 月