辉瑞抗癌药Xalkori获FDA正式批准

辉瑞（Pfizer）11月21日宣布，抗癌药物Xalkori（crizotinib）获得了FDA的正式批准，用于经FDA批准的一款检测试剂盒证实其肿瘤为间变性淋巴瘤激酶（ALK）阳性的转移性非小细胞肺癌（NSCLC）患者的治疗。

出于ALK阳性NSCLC患者对新药迫切需求的考虑，FDA于2011年8月授予了Xalkori加速批准（accelerated approval）。

肺癌是癌症致死的主要原因之一，据估计，每年约有140万人死于肺癌。迄今为止，在全球范围内，有超过6000例患者已接受了Xalkori治疗，包括那些在临床试验中接受Xalkori治疗的患者。在美国，ALK检测率已增加了5倍多，从Xalkori上市前的11%增至如今的超过60%。

Xalkori已极大地改变了晚期ALK阳性NSCLC患者的临床治疗。

FDA的行动，标志着由一个加速批准向正式批准的转变。Xalkori的正式批准，是基于关键性III期PROFILE 1007确证试验（confirmatory trial）的数据，该项研究在既往治疗过的患者中开展，将Xalkori与标准化疗进行了对比，该项研究的完整数据已发表于2013年6月20日的《新英格兰医学杂志》（NEJM）。

除美国外，Xalkori已获全球60多个国家批准，包括欧盟、加拿大、中国、韩国、日本、澳大利亚。

Xalkori是一种激酶抑制剂，旨在用于经FDA批准的一种检测试剂盒证实其肿瘤为间变性淋巴瘤激酶（ALK）阳性的转移性非小细胞肺癌（NSCLC）患者的治疗。

英文原文：Pfizer’s XALKORI? Granted Regular FDA Approval

Standard of Care for Patients With Metastatic ALK-Positive Non-Small Cell Lung Cancer

Thursday, November 21, 2013 - 11:00am EST

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Pfizer’s XALKORI? (crizotinib) regular approval for the treatment of patients with metastatic ALK-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.  XALKORI was previously granted accelerated approval in August 2011 due to the critical need for new agents for people living with ALK-positive NSCLC.

Lung cancer is the leading cause of cancer death worldwide[1] with an estimated 1.4 million deaths each year.[2]  To date, globally more than 6,000 patients have been treated with XALKORI, including those who received XALKORI in clinical trials.  ALK testing rates in the U.S. have increased more than 5-fold from 11 percent before the XALKORI launch to more than 60 percent.[3]

"XALKORI has dramatically changed the treatment landscape for patients with advanced ALK-positive NSCLC," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit. "Achievement of this milestone underscores Pfizer’s commitment to provide physicians with effective cancer therapies for their patients.”

The FDA’s action marks the conversion of an accelerated approval to regular approval and is based on data from the pivotal Phase 3 PROFILE 1007 confirmatory trial comparing XALKORI to standard chemotherapy in previously treated patients.  The results of this study were recently published in the June 20, 2013 issue of the New England Journal of Medicine.

In addition to the U.S., XALKORI has received approval in more than 60 countries, including EU, Canada, China, Korea, Japan and Australia.

XALKORI is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.