昨天，一种名为“拉帕替尼”的抗乳腺癌新药获准在美国上市与之前的抗乳腺癌药物不同，“拉帕替尼”可以寻找到癌变细胞并从内部加以攻击。一项跟踪研究表明，患者配合化疗服用这种新药，可以延长癌细胞的稳定时间，将扩散的速度减半。目前这种新药成本还很高，一个月的花费大概要在24000元人民币左右。 DA Approves Tykerb for Advanced Breast Cancer Patients
The Food and Drug Administration (FDA) today approved Tykerb (lapatinib),
a new targeted anti-cancer treatment, to be used in combination with
capectabine (Xeloda), another cancer drug, for patients with advanced,
metastatic breast cancer that is HER2 positive (tumors that exhibit HER2
protein). The combination treatment is indicated for women who have
received prior therapy with other cancer drugs, including an
anthracycline, a taxane, and trastuzumab (Herceptin). According to the
American Cancer Society, about 180,000 new cases of breast cancer are
diagnosed each year. Approximately 8,000 to 10,000 women die from
metastatic HER2 positive breast cancer each year.
Tykerb, a new molecular entity (NME), is a kinase inhibitor working
through multiple pathways (targets) to deprive tumor cells of signals
needed to grow. Unlike, for example, trastuzumab — a monoclonal antibody,
which is a large protein molecule that targets the part of the HER2
protein on the outside of the cell — Tykerb is a small molecule that
enters the cell and blocks the function of this and other proteins.
Because of this difference in mechanism of action, Tykerb works in some
HER2 positive breast cancers that have been treated with trastuzumab and
are no longer benefiting.
\"Today\'s approval is a step forward in making new treatments available for
patients who have progression of their breast cancer after treatment with
some of the most effective breast cancer therapies available,\" said Steven
Galson, MD, M.P.H., Director of FDA\'s Center for Drug Evaluation and
Research. \"New targeted therapies such as Tykerb are helping expand
options for patients.\"
The approval of Tykerb was based on a randomized clinical trial in about
400 women with advanced or metastatic breast cancer that was also HER2
positive. In the trial, half the patients received Tykerb with
capecitabine and half received capecitabine alone. Compared to patients
receiving capecitabine alone, the group of patients receiving Tykerb with
capecitabine had a statistically significant improvement in the time to
tumor progression. In addition, the tumor response rate was higher in the
group of patients receiving Tykerb with capecitabine (24 percent vs. 14
percent). The survival data are not yet mature.
The most commonly reported Tykerb-related side effects included diarrhea,
nausea, vomiting, rash and hand-foot syndrome which may include numbness,
tingling, redness, swelling and discomfort of hands and feet. Generally
reversible decreases in heart function (that can lead to shortness of
breath) have also been reported in a small percentage of patients.
Patients should talk to their doctor about potential side effects,
potential drug interactions, and other medical conditions including heart
and liver problems. Tykerb is available in tablets of 250 mg. An undivided
dose of 1,250 mg should be taken orally once daily for 21 days and in
combination with capecitabine on days 1-14 of a 21 day cycle.
Tykerb will be distributed by GlaxoSmithKline, of Research Triangle Park,
North Carolina.
最近，美国的研究人员正在对一种抗乳腺癌新药进行临床实验，临床实验结果表明，这种新药可能会对延长晚期乳腺癌患者的生命有所帮助。 这种新药名叫Tykerb，是葛兰素史克公司研制的。临床试验显示，对于那些已对罗氏的赫赛汀（Herceptin）产生耐药性的HER2型乳癌患者，这种新药有很好的临床效果。根据一项针对321名乳腺癌患者的跟踪研究，在进行化疗时如果配合服用这种新药，37周内癌症不会继续扩散；但是如果单纯进行化疗，则只有20周的时间不继续扩散。 有一位名叫洛林的妇女，乳腺癌晚期，扩散的非常快，她按照常规接受了赫赛汀的治疗，一年内并没有出现扩散，但是一年后，却突然发现癌症已经脑转移。之后，洛林参与了新药的临床试验，她脑部的肿瘤出现了收缩的迹象。研究人员认为这一疗效非常令人振奋。 目前，研究人员正在将Tykerb试用于早期乳腺癌患者的治疗，以及肾脏癌，脑转移癌症患者的临床研究中
发布时间：2007年04月09日