Accelerated Approval for Pertuzumab in the Neoadjuvant Setting: Winds of Change?
Accelerated Approval for Pertuzumab in the Neoadjuvant Setting: Winds of Change?
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DOI：
10.1158/1078-0432.ccr-13-3131
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发表时间：
2014-07-15
影响因子：
11.5
通讯作者：
DeMichele, Angela
中科院分区：
文献类型：
--
作者：
Esserman, Laura J.;DeMichele, Angela
加速批准可提高原发性乳腺癌完全病理反应频率的药物预示着将有效药物更快推向市场的机会不断扩大。然而，这些新途径将需要确定药物最有效的特征或亚型，以及患者参加试验的证据，从而能够确定无事件生存。最近批准帕妥珠单抗用于新辅助治疗证明 FDA 致力于支持加速批准途径。讨论了可能获得批准的情况。 (C)2014 AACR。
Accelerated approval for agents that improve the frequency of complete pathologic response in the primary breast cancer setting heralds a broadening of the opportunities to get effective agents to the market more quickly. However, these new pathways will require identifying the signature or subtype for which the agent is most effective, and evidence of enrollment of patients to a trial that enables the ascertainment of event-free survival. The recent approval of pertuzumab for use in the neoadjuvant setting is evidence that the FDA is committed to supporting the accelerated approval pathway. The situations in which approval is likely to be granted are discussed. (C)2014 AACR.