FDA核准Bevacizumab用於治療轉移性腎細胞腎癌


  August 4, 2009 — 美國食品藥物管理局(FDA)已經核准bevacizumab靜脈輸注劑(Avastin,Genetech藥廠)的新適應症,用於治療轉移性腎細胞腎癌。建議劑量為每兩週注射10 mg/kg,合併干擾素α-2a(每週三次皮下注射9 MIU)。
  
  Bevacizumab是一個透過與血管內皮細胞生長因子結合的單株抗體,因此可以抑制血管新生。抑制血管新生會使腫瘤喪失血液、氧氣以及其他維持腫瘤生長與轉移的營養物質。
  
  腎臟癌症學會執行主任William P. Bro在一家公司新聞稿中表示,我們希望研究團隊有一天發現治癒腎臟癌症的方法。直到那時候,每個新藥都提供病患一個發現最適合他們治療的機會。
  
  這項適應症的核准主要是根據一項全球性、隨機分派、雙盲、安慰劑控制第三期研究,稱為the Avastin in Renal(簡稱AVOREN)研究,這項研究收納了649位新診斷罹患轉移性腎癌患者,證實干擾素α-2a加上bevacizumab,相較於僅使用干擾素α-2a,顯著增加免於惡化存活率達67%(10.2個月相較於5.4個月;危險比值[HR]為0.60;95%信賴區間[CI]為0.49-0.72)。
  
  研究結果顯示,相較於僅使用干擾素α-2a的12%,合併治療顯著降低腫瘤大小達30%。然而,在發生444件死亡事件後的最終分析,整體存活率中位數並沒有改善(存活時間,23個月相較於21個月;HR為0.86;95% CI為0.72-1.04)。
  
  這項研究中通報的不良反應事件與bevacizumab及干擾素α-2a的安全性資料相符,最常報告的包括疲倦(13%)、虛弱(10%)、蛋白尿(7%)、高血壓(6%)與出血(3%)。
  
  Bevacizumab過去被核准用於轉移性大腸直腸癌、非扁皮細胞非小細胞肺癌、轉移性乳癌與神經膠母細胞瘤。
  

FDA Approves Bevacizumab for Treatment of Metastatic Renal Cell Carcinoma

By Yael Waknine
Medscape Medical News

August 4, 2009 — The US Food and Drug Administration (FDA) has approved a new indication for bevacizumab intravenous infusion (Avastin, Genentech, Inc) for the treatment of metastatic renal cell carcinoma. The recommended dose is 10 mg/kg every 2 weeks in combination with interferon α-2a (9 MIU subcutaneously 3 times weekly).

Bevacizumab is a monoclonal antibody that works by binding to vascular endothelial growth factor and preventing its role in angiogenesis, which deprives tumors of blood, oxygen, and other nutrients necessary to support their growth and metastasis.

"We hope that researchers someday find a cure for kidney cancer," said William P. Bro, chief executive officer of the Kidney Cancer Association in a company news release. "Until then, each new medicine...offers patients an opportunity to find a treatment best suited for them."

Approval of the indication was based on data from a global, randomized, double-blind, placebo-controlled phase 3 study — the Avastin in Renal (AVOREN) study — of 649 patients with newly diagnosed metastatic renal cell carcinoma, showing that the addition of bevacizumab to interferon α-2a significantly increased progression-free survival by 67% compared with interferon α-2a alone (10.2 months vs 5.4 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.49 – 0.72).

Results also showed that the combination therapy significantly decreased tumor size by 30% compared with 12% for interferon α-2a alone. However, no improvements were observed in median overall survival on the final analysis after 444 deaths (survival, 23 months vs 21 months; HR, 0.86; 95% CI, 0.72 – 1.04).

Adverse events reported in the study were consistent with the safety profiles for bevacizumab and interferon α-2a, with fatigue (13%), weakness (10%), proteinuria (7%), hypertension (6%), and bleeding (3%) most often reported.

Bevacizumab previously was approved for the treatment of metastatic colorectal cancer, nonsquamous non-small cell lung cancer, metastatic breast cancer, and glioblastoma.

    
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