美國食品藥物管理局核准新的腎癌藥物組合
FDA approves new kidney cancer drug combination
Updated at: September 28, 2026 at 12:15 AM
2026年9月24日，美國食品藥物管理局(FDA)在核准了一項用於晚期腎癌患者的新型藥物組合後，達成了一項醫學里程碑。
On September 24, 2026, the U.S.
該療法涉及將 belzutifan (WELIREG) 與 lenvatinib (LENVIMA) 結合，適用於先前已接受過免疫檢查點抑制劑治療的晚期腎細胞癌(Renal Cell Carcinoma，簡稱RCC)成年患者。
Food and Drug Administration (FDA) reached a medical milestone by approving a new drug combination for patients with advanced kidney cancer.
此新方案尤具意義，因其將首個同類(First-in-class)的 HIF-2α 抑制劑引入了二線治療。
The treatment involves pairing belzutifan (WELIREG) with lenvatinib (LENVIMA) for adults with advanced renal cell carcinoma who have already undergone treatment with immune checkpoint inhibitors.
該核准是基於第三期 LITESPARK-011 臨床試驗的結果，該試驗將此藥物組合與標準療法進行了比較。
This new protocol is particularly significant because it introduces a first-in-class HIF-2α inhibitor into the second-line setting.
此外，客觀緩解率(Objective response rate)達到53%，為疾病已惡化的患者提供了具希望的替代療法。
Participants using the duo demonstrated a median progression-free survival of 14.6 months, compared to 10.6 months for those in the control group.
儘管該組合帶來了新希望，患者與醫療人員仍須謹慎管理潛在副作用，包括高血壓(Hypertension)、貧血(Anemia)與心臟功能障礙(Cardiac dysfunction)。
Furthermore, the objective response rate reached 53%, providing a promising alternative for those whose disease has progressed.
藉由提供一種非免疫治療的策略，此項核准解決了關鍵的醫療需求，為正克服晚期腎癌挑戰的患者提供了至關重要的全新選擇。
While the combination offers new hope, patients and providers must carefully manage potential side effects, including hypertension, anemia, and cardiac dysfunction.
