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治癌藥物首重基因而非腫瘤位置 Keytruda成為第一種適用所有原發部位的癌症用藥
27/05/2017

作者 : Helen Law / 癌症資訊網 ( 综合報導 )

 

治癌藥物首重基因而非腫瘤位置

 

免疫治療是癌症治療的突破,更多患者將因此而得益。

 

就精準醫療而言,一種治療癌症的藥物首次得到監管機構的批准。該藥物的機制是根據腫瘤的基因特徵,而非腫瘤在體內的位置。

 

2017年​5月​23日​,美國食品和藥物管理局(FDA)表示已批准一種免疫療法藥物Keytruda,用於所謂「錯配修復」基因導致的遺傳性疾病的患者。

 

這些基因突變意味著它們的細胞不能完全修復DNA在生長和分裂過程中出現的錯誤,這可能引發癌症,這類腫瘤對由Merck銷售的Keytruda反應特別理想 。

 

FDA藥物評估及研究中心的血液及腫瘤學產品辦公室署理總監Richard Pazdur在一份聲明中稱,該批准是「癌症群體中最重要的進展」。

 

精準醫療的意念是根據別患者的基因特徵及其他相關資訊,來擬訂個人化的治療方法。然而,迄今為止,癌症的治療一直根據腫瘤的所在位置,例如乳腺癌或肺癌。

 

Keytruda是第一種藥物,可以給予同時擁有兩個相對罕見的異常基因,並且患有實體腫瘤的人,例如胰腺癌或肺癌患者。 一家諮詢公司Bionest Partners的執行合夥人Olivier Lesueur稱,這個批准是「我們所見定義癌症的方式的突破」。

 

Keytruda透過動人體的免疫系統來攻擊腫瘤,並於2014年首次被批准用於治療晚期皮膚癌。這種稱為「檢點抑制劑」的藥物取得了顯著的成功,包括挽救了前美國總統Jimmy Carter的生命。然而,免疫治療的缺點是,似乎並非所有患者都能得益,其原因尚不明確。

 

隨著FDA的核准期能得益的患者人可能大幅增霍普金斯大彭博金梅免疫治研究所的Dung Le4%的晚期癌症患者一年多30,000名患者 - 帶有Keytruda能夠治療的異常基因。

 

「這種藥物可以幫助到一些我們以前無法提供治療的患者。」Dung Le說。

 

Keytruda僅適用於接受傳統治療(如化療)失敗的患者。但是,Dung Le認為基因檢測可以廣泛地使用於確定異常基因,費用在300600美元之間,而Keytruda 的費用約為每年15萬美元。

 

約翰霍普金斯大學醫院和其他四所醫院進行一項臨床試驗,涉及149名患有15種不同類型癌症的患者。在該試驗中,約40% 患者的腫瘤完全消失或明顯縮小。這使Merck的申請獲得「加速」批准。

其中一名患者Adrienne Skinner,60歲,來自紐約州Larchmont。她在2013年被診斷患有晚期壺腹癌(一種罕見且致命的胃腸癌)後,經歷了一年的化療。

 

2014年4月,Skinner參加了Keytruda臨床研究。她是一名候選人,因為她一出生便患有遺傳性的Lynch Syndrome,其DNA修復基因無法正常地工作。 在參加Keytruda臨床研究的短短幾個月裡,一名外科醫生為她檢查,並告訴她體內的腫瘤已經消失了。

 

Skinner繼續服用Keytruda兩年,並表示她現在覺得自己回復正常了。她現時有全職工作,常常到健身房、打網球、做瑜伽。她說:「如果沒有Keytruda的出現,我已離開了這個世界。」


 
FDA News Release
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm

 

 

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