FDA批准Erbitux用于治疗晚期直肠癌

来自FDA官方网站的信息----2月13日，FDA宣布批准Imclone 公司的Erbitux(cetuximab)用于对癌症小知识：癌症状：恶性淋巴瘤的全身症状因疾病类型及所处的期间分歧而差别很年夜，部门患者可无全身症状。有症状者以发热、肥胖(体重减轻10％以上)、盗汗等较为常见，其次有欲减退、易委靡、瘙痒等。全身症状和病发春秋、肿瘤规模、机体免疫力等有关。老年患者、免疫功能差或多灶性起病者，全身症状显著。无全身症状者，其存活率较有症状者年夜3倍。淋巴癌的临床表示1、发热:热型多不法则，可呈延续高热，也可间歇低热，少数有周期热，后者约见于1／6霍奇金病患者。初期发热者霍奇金病约占30％一50％，但非霍奇金淋巴瘤一般在病变较普遍时才发热。热退时年夜汗淋漓可为本病特征。淋巴癌的临床表示2、皮肤瘙痒:这是霍奇金病较特异的表示。局灶性瘙痒产生于病变部淋巴引流的区域，全身瘙痒年夜多产生于纵隔或腹部有病变的病例。淋巴癌的临床表示3、酒精疼痛:约17％一20％霍奇金病患者，在喝酒后20分钟，病变局部产生疼痛。其症状可早于其他症状及X线表示，...已发生转移的晚期直肠癌患者的治疗。Erbitux是第一种被批准用于此类适应症的单克隆抗体，FDA批准其通过静脉给药的方式与依立替康联用或在患者无法耐受依立替康时单独用药。临床试验显示，Erbitux虽然不能延长患者的存活期，但可以减小某些患者体内肿瘤小知识：肿瘤细胞无停止和无规律的异常增生，且发育不良，不具有正常成熟细胞的功能，并在其发展历程中不竭向周围组织侵犯，向区域淋凑趣和远处器官转移，使正常组织的布局和功能遭到粉碎，这类播散如得不到节制，最初将导致机体死亡。 ...的并大小并减缓肿瘤的生长速度，特别是在其与依立替康联用时。Erbitux主要通过靶向作用于癌细胞表面的表皮生长因子（EGFR），来干扰癌细胞的生长，达到临床治疗的目的。Erbitux将由百时美施贵宝公司负责上市销售。FDA同日也批准了由DakoCytomation加州公司生产的用于分析直肠组织样本的检测试剂。据称，这种试剂可检测到体内是否存在一种能刺激癌组织生长的名为HER-1的蛋白。如果检测到这种蛋白，则表明病人适合使用Erbitux进行治疗 。

生产商：Imclone 公司
销售商：美国施贵宝公司

规格：50ML x1(2mg/ml)

零售价：

FDANEWS
FDA Approves Erbitux for Colorectal Cancer
FDA today approved Erbitux (cetuximab) to treat patients with advanced colorectal cancer that has spread to other parts of the body. Erbitux is the first monoclonal antibody approved to treat this type of cancer and is indicated as a combination treatment to be given intravenously with irinotecan, another drug approved to fight colorectal cancer, or alone if patients cannot tolerate irinotecan.

Erbitux was approved under FDAs accelerated approval program, which allows FDA to approve products for cancer and other serious or life-threatening diseases based on early evidence of a products effectiveness. Although treatment with Erbitux has not been shown to extend patients lives, it was shown to shrink tumors in some patients and delay tumor growth, especially when used as a combination treatment.

Erbitux is a genetically engineered version of a mouse antibody that contains both human and mouse components. (Antibodies in the body are substances produced by the immune system to fight foreign substances.) It can be produced in large quantities in the laboratory. This new monoclonal antibody is believed to work by targeting a natural protein called "epidermal growth factor receptor" (EGFR) on the surface of cancer cells, interfering with their growth.

For patients with tumors that express EGFR and who no longer responded to treatment with irinotecan alone or in combination with other chemotherapy drugs, the combination treatment of Erbitux and irinotecan shrank tumors in 22.9% of patients and delayed tumor growth by approximately 4.1 months. For patients who received Erbitux alone, the tumor response rate was 10.8% and tumor growth was delayed by 1.5 months.

Colorectal cancer -- cancer of the colon or rectum -- is the third most common cancer affecting men and women in the U.S. and, according to the Centers for Disease Control and Prevention (CDC), and is the second leading cause of cancer-related death. Colorectal cancer is also one of the most commonly diagnosed cancers in the U.S.; approximately 147,500 new cases were diagnosed in 2003.

"In their review activities, FDA staff work hard to ensure doctors and patients can have confidence in the safety and effectiveness of new therapies such as Erbitux," said Mark B. McClellan, M.D., Ph.D. "FDA believes it is crucial for cancer patients to have many proven treatment options in their battle against this disease."

The efficacy and safety of Erbitux alone or in combination with irinotecan were studied in a randomized, controlled trial with 329 patients and also in combination with irinotecan in 138 patients in which all patients received both drugs. Erbitux was further evaluated as a single agent in a third clinical trial with 57 patients. Safety data from an additional 111 patients treated only with Erbitux was also evaluated. All of the trials included patients with EGFR-expressing metastatic colorectal cancer, whose disease had progressed after receiving irinotecan.

The manufacturer of Erbitux, ImClone Systems Incorporated, Branchburg, N.J., submitted their original request for approval in several sections between June 28 and October 31, 2001. Subsequent to ImClones original submissions, FDA determined that their application could not be reviewed because approximately half of the patients (94) studied had not failed the approved treatments for colon cancer; and important information about the safety and effectiveness of Erbitux in a portion of the remaining patients (102) was missing. In their new request for approval on August 14, 2003, Imclone submitted the results of a large, well-run trial that included 329 patients as well as the results of the earlier two studies. For the studies submitted in their original 2001 request for approval, ImClone successfully collected substantial amounts of missing information from hospital records and other sources.

Two studies involving approximately 2000 patients are currently underway to assess the clinical benefits of Erbitux. These studies are specifically examining the ability of Erbitux to stop the progression of colorectal cancer and to extend the amount of time patients survive with the disease.

Erbitux can cause serious side-effects, usually during the administration of the first treatment, which may include difficulty breathing and low blood pressure. Infrequent interstitial lung disease (ILD) has been reported; however, it is difficult to determine if Erbitux caused ILD. ILD occurs when the lung becomes stiff due to scarring of the tissue between the air sacs of the lungs.

Other more common side-effects of Erbitux treatment include acne-like rash, dry skin, tiredness or weakness, fever, constipation, and abdominal pain.

Erbitux will be distributed and marketed by Bristol-Myers Squibb Company, Princeton, N.J.

FDA also today approved a test kit, manufactured by DakoCytomation California, Inc., that is used by doctors to analyze a colon tissue sample. The kit detects a protein in the body (HER-1) that stimulates cancerous tissue cell growth. Presence of this protein indicates that a patient is eligible for colon cancer treatment with Erbitux.