ST LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved the injectable drug degarelix, the first new drug in several years for prostate cancer.

Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.

Hormonal treatments for prostate cancer may cause an initial surge in testosterone production before lowering testosterone levels. This initial stimulation of the hormone receptors may temporarily prompt tumor growth rather than inhibiting it. Degarelix doesn't do this.

"Prostate cancer is the second leading cause of cancer death among men in the United States, and there is an ongoing need for additional treatment options for these patients," said Richard Pazdur, MD, director of the Office of Oncology Drug Products, Center for Drug Evaluation and Research, FDA.

Prostate cancer is one of the most commonly diagnosed cancers in the United States. In 2004, the most recent year for which statistics are available, nearly 190,000 men were diagnosed with prostate cancer, and 29,000 men died from the cancer.

Several treatment options exist for different stages of prostate cancer, including observation, prostatectomy (surgical removal of the prostate gland), radiation therapy, chemotherapy, and hormone therapy with agents that affect GnRH receptors.

The efficacy of degarelix was established in a clinical trial in which patients with prostate cancer received either degarelix or leuprolide, a drug currently used for hormone therapy in treating advanced prostate cancer. Degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs that affect GnRH receptors.

In fact, nearly all the patients on either drug had suppression of testosterone to levels seen with surgical removal of the testes.

The most frequently reported adverse reactions in the clinical study included injection-site reactions (pain, redness, and swelling), hot flashes, increased weight, fatigue, and increases in some liver enzymes.

Degarelix is manufactured for Ferring Pharmaceuticals Inc, Parsippany, NJ, by Rentschler Biotechnologie Gmbh, Laupheim, Germany.  

圣路易斯（MD Consult）——美国食品与药物管理局（FDA）批准新型注射药剂degarelix上市。这是数年来首个获FDA批准的治疗前列腺癌新药。

Degarelix主要用于治疗晚期前列腺癌患者，属于促性腺激素释放激素（GnRH）受体抑制剂类药物，通过抑制睾酮（在前列腺癌持续生长中具有重要作用）来延缓前列腺癌生长和病程进展。

前列腺癌的激素治疗方案可能会在治疗初期在降低睾酮水平之前先刺激睾酮水平激增。这意味着在治疗初期对激素受体的刺激会暂时促进肿瘤生长而不是抑制其生长。而Degarelix从一开始就能抑制前列腺癌。

FDA药物评价和研究中心肿瘤药物产品办公室主任Richard Pazdur 博士称：“前列腺癌是美国男性第二位的癌症死亡原因，此类患者需要更多的治疗方案”。

前列腺癌是美国确诊最多的癌症之一。最近的2004年数据显示，美国该年共有将近190,000例男性被确诊前列腺癌，29,000例男性死于该病。

目前对于不同期前列腺癌已经有了几种治疗方案，包括观察等待、前列腺切除术（手术切除前列腺）、放射治疗、化学治疗和应用作用于GnRH受体的药物激素治疗。

Degarelix的疗效已经在一项临床试验中得到证实。在该项研究中，前列腺癌患者接受Degarelix或亮丙瑞林（一种目前用于治疗晚期前列腺癌的激素治疗药物）。Degarelix治疗并不引起睾酮水平的暂时升高（其他一些作用于GnRH受体的药物应用后可见到升高）。

实际上，两种药物都可以使几乎所有患者的睾酮水平降低到手术切除睾丸后的水平。

Degarelix临床研究中最常报告的不良反应包括注射部位反应（疼痛和红肿）、潮热、体重增加、疲劳，以及某些肝酶水平升高。

Degarelix由Rentschler Biotechnologie Gmbh公司（德国劳普海姆）为辉凌（Ferring）制药公司制造（新泽西州帕瑟伯尼）。

爱思唯尔 版权所有