粮食与药物管理局在治疗今天发表了以下声明关于一次临床试验的疏忽Iressa (gefitinib)显示整体生存好处患者与肺癌： 粮食与药物管理局(粮食与药物管理局)从AstraZeneca昨天获悉一次大临床试验Iressa (gefitinib)与安慰剂比较在有发生故障的非小细胞肺癌的病人癌症疗法其他路线没有显示从采取Iressa的生存好处。 当前采取Iressa的患者应该尽快与他们的医师协商; 患者不应该改变他们的疗法不首先与他们的医师协商。 供选择的疗法是可利用的。 粮食与药物管理局批准了Taxotere (docetaxel)和Tarceva (erlotinib)，其中之二在研究在病人显示改进生存有非小细胞肺癌癌症在早先疗法时进步了，当 粮食与药物管理局被批准的Iressa在2003年5月2日，根据代办处的加速的认同(子部分H)节目，为病人的治疗有发生了故障化疗两个或多个路线的非小细胞肺癌的。 加速的认同供应在粮食与药物管理局的章程允许代办处批准一种药物为根据作用的行销对一个代理人终点 -- 例如疾病的标志或实验室试验的结果 -- 那合理地可能被考虑预言临床好处(被改进的症状或生存)。
The FDA today released the following statement regarding the failure of a clinical trial of Iressa (gefitinib) to show an overall survival advantage in treating patients with lung cancer:
The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival benefit from taking Iressa.
Patients currently taking Iressa should consult with their physicians as soon as possible; patients should not change their therapy without first consulting with their physicians.
Alternative therapies are available. FDA has approved Taxotere (docetaxel) and Tarceva (erlotinib), both of which have been shown in studies to improve survival in patients with non-small cell lung cancer whose cancer has progressed while on previous therapies.
FDA approved Iressa on May 2, 2003, under the Agency's accelerated approval (Subpart H) program, for the treatment of patients with non-small cell lung cancer who had failed two or more courses of chemotherapy. The accelerated approval provisions in FDA's regulations allow the agency to approve a drug for marketing based on an effect on a surrogate endpoint -- such as a sign of a disease or the results of a laboratory test -- that is considered reasonably likely to predict clinical benefit (improved symptoms or survival). Iressa was approved because the data from clinical trials showed that it caused significant shrinkage in tumors in about 10% of patients, and this was thought likely to increase patients' overall survival time.
One requirement for drugs approved under the agency's accelerated approval program is that the sponsor must study them further after approval to verify the expected clinical benefit. After the approval of Iressa in 2003, AstraZeneca conducted a study in approximately 1700 patients to determine whether the drug would in fact prolong survival in comparison to patients taking placebo. The results announced today indicate that the drug did not prolong survival. Under FDA's accelerated approval program, the Agency has the authority to remove a drug from the market if a postmarketing clinical study fails to verify clinical benefit. After FDA has evaluated the recent study results, FDA will determine whether Iressa should be withdrawn from the market or if other regulatory actions are appropriate.
点击数：
抗癌在线首页
>> 肿瘤药房 >> 西药 >> 研究中抗肿瘤药品