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(wèi)被批準(zhǔn)用于五種新適應(yīng)癥　　

 

美國食品藥品監(jiān)督管理局批準(zhǔn)諾華公司藥物格列衛(wèi)（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(wèi)的這5種新適應(yīng)癥如下：　　

 

無法切除的、轉(zhuǎn)移性和（或）復(fù)發(fā)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(xì)胞性白血病；　

 

與血小板源性生長因子受體（PDGFR）基因排列相關(guān)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(xì)胞過多綜合癥或慢性嗜酸性粒細(xì)胞性白血病患者；

 

無D816V基因突變或不明基因突變的系統(tǒng)性肥大細(xì)胞增多癥；

 

這是FDA首次批準(zhǔn)一個藥物同時用于5種新適應(yīng)癥。