格列衛被批準用于五種新適應癥

英文原文：　

 

 

Novartis’ agent Gleevec (imatinib mesylate) has been approved by the United States Food and Drug Administration for the treatment of five rare and life-threatening diseases in which limited treatment options exist. The new indications regarding treatment with Gleevec include the following:

 

Unresectable, metastatic and/or recurrent dermatofibrosarcoma protuberans　

 

Relapsed/Refractory Philadelphia chromosome-positive acute lymphoblastic leukemia

 

Myelodysplastic/myeloproliferative diseases associated with PDGFR (platelet derived growth factor receptor) gene arrangements

 

Hypereosinophilic syndrome/chronic eosinophilic leukemia patients who have the FIP1L1-PDGFR alpha fusion kinase (mutational analysis or FISH demonstration CHIC2 allele deletion) or those who are FIP1L1-PDGFR alpha fusion kinase negative or unknown

 Aggressive systemic mastocytosis without the D816V c-kit mutation, or those with unknown c-kit mutational status
　

This is the first time that the U.S. FDA has granted five new indications to an agent at one time.

 

參考譯文：

格列衛被批準用于五種新適應癥　　

 

美國食品藥品監督管理局批準諾華公司藥物格列衛（甲磺酸伊馬替尼）治療5種罕見的、危及生命的、目前鮮少治療辦法的疾病。格列衛的這5種新適應癥如下：　　

 

無法切除的、轉移性和（或）復發性的隆凸性皮膚纖維肉瘤；　　

 

頑固性費城染色體陽性的急性成淋巴細胞性白血病；　

 

與血小板源性生長因子受體（PDGFR）基因排列相關的骨髓異常增生疾病；

 

FIP1L1/PDGFR-α融合基因陽性或陰性嗜酸性粒細胞過多綜合癥或慢性嗜酸性粒細胞性白血病患者；

 

無D816V基因突變或不明基因突變的系統性肥大細胞增多癥；

 

這是FDA首次批準一個藥物同時用于5種新適應癥。