FDA approves new kidney cancer drug combination
美國食品藥物管理局核准新的腎癌藥物組合
更新於: 2026年9月28日 上午12:15
On September 24, 2026, the U.S.
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。
Food and Drug Administration (FDA) reached a medical milestone by approving a new drug combination for patients with advanced kidney cancer.
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。
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.
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 approval follows the results of the phase 3 LITESPARK-011 clinical trial, which compared this combination against standard treatments.
使用該組合的受試者中位無惡化存活期(Progression-free survival)為14.6個月，而對照組則為10.6個月。
While the combination offers new hope, patients and providers must carefully manage potential side effects, including hypertension, anemia, and cardiac dysfunction.
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。
By offering a non-immunotherapy strategy, this approval addresses a critical medical need, providing a vital new option for patients navigating the challenges of advanced kidney cancer.
