Many cancer drugs unproven 5 years after accelerated approval 許多抗癌藥物在加速批准 5年後仍未證實有效－【精英翻譯】的部落格

精英翻譯轉自https://features.ltn.com.tw/english/article/paper/1643272

◎陳成良

The U.S. Food and Drug Administration’s accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients’ lives?

美國食品暨藥物管理局（FDA）的加速批准計畫，旨在讓患者儘早獲得可能有效的藥物。但是，這些藥物實際上多久能改善或延長患者的生命呢？

In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years.

在一項新研究中，研究人員發現，大多數獲得加速批准的抗癌藥物，在隨後5年內並未證實其療效。

The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs.

該計畫創建於1992年，旨在加快獲得用於治療愛滋病毒藥物的速度。如今，85％的加速批准用於抗癌藥物。

The new study found that between 2013 and 2017, there were 46 cancer drugs granted accelerated approval. Of those, 63% were converted to regular approval even though only 43% demonstrated a clinical benefit in confirmatory trials. (AP)

這項新研究發現，在2013年至2017年期間，有46種抗癌藥物獲得加速批准。其中，63％轉為常規批准，儘管只有43％在驗證性試驗中顯示臨床益處。