辉瑞3月25日宣布Xalkori(克唑替尼)一线治疗ALK+晚期NSCLC患者的PROFILE 1014 III期临床研究到达主要终点。PROFILE 1014研究首次证明Xalkori一线用药相比以铂类药物为基础的二联标准化疗方案能显著延长PFS。Xalkori目前已在包括中国在内的74个国家获批。

Pfizer Cancer Drug Xalkori Shows Positive Results as First-Line Remedy

Pfizer Inc. said its Xalkori cancer drug was superior to chemotherapy as a first-line treatment for a certain type of advanced non-squamous non-small cell lung cancer in a recent Phase III study.

The study finding builds on data from a previous Phase III study, according to Dr. Mace Rothenberg, chief medical officer for Pfizer Oncology. Together, the studies establish Xalkori as a standard of care in both the first- and second-line setting.

Xalkori is designed to treat the approximately 5% of non-small cell lung cancer patients who test positive for alterations in a gene known as ALK. Many ALK-positive patients are those who have never smoked and who are younger than most ALK-negative patients with the deadly disease.

U.S. regulatory approval of Xalkori in 2011, along with a companion diagnostic to screen for ALK alterations, was based on studies showing the drug shrank tumors in 50% to 60% of ALK-positive lung cancer patients.

Like other major drug makers, Pfizer has been aiming to introduce new drugs and expand the uses for current ones to replac sales lost as patents expire for former top-selling medicines.

免责声明： 

      本文仅供专业人士学术交流探讨，不作为诊疗及用药依据。 

      如有侵权，请联系我们删除