Nat Med. 2013 Jun;19(6):660-3. doi: 10.1038/nm.3245. Epub 2013 Jun 2.
A new regulatory pathway established last year allows drugs with dramatic early clinical promise to be expedited to the market quicker than ever before. To date, most of these 'breakthrough' designations have gone to cancer agents, raising the prospect of faster access to the latest lifesaving therapies for the estimated 4,500 people newly diagnosed with cancer each day in the US. Elie Dolgin looks at what sets these breakthrough medicines apart.
去年建立的一条新监管途径使具有显著早期临床前景的药物能够比以往任何时候都更快地推向市场。迄今为止，这些“突破性”指定大多数都用于癌症药物，为每天在美国新诊断出癌症的约 4500 人提供更快获得最新救生疗法的前景。Elie Dolgin 探讨了这些突破性药物的不同之处。
