| FDA核准Gleevec(Imatinib mesylate)作为肠胃道基质肿瘤的治疗 | |
| 作者：Laurie Barclay, MD | |
| 出处：WebMD 医学新闻 | |
December 23, 2008 — 12月19日，美国食品药物管理局（FDA）核准imatinib mesylate（Gleevec，诺华药厂制造）用于预防手术后肠胃道基质肿瘤的再发。 FDA药物评估与研究中心肿瘤药物产品主任Richard Pazdur医师在一篇新闻稿中表示，Gleevec的核准提供了健康照护者与罹患这种罕见肠胃道疾病病患一个重要的新治疗选择，显示继续研究已上市药物在整个产品生命周期中也可以产生新的与重要的用途。 GIST是一个源自于肠胃道Cajal细胞的罕见癌症，这是一种排列与调控胃肠食物与液体流动的自律神经系统细胞。在美国，GIST的发生率每年大约有5,000至6,000个新诊断病例。 GIST的早期诊断会因为非特异性症状，例如恶心与呕吐而被忽略。虽然外科切除是第一线治疗，但GIST通常会再发。Imatinib适用于术后帮助预防GIST再发。 一项临床研究显示，手术切除后以imatinib治疗一年，在预防肿瘤再发上比安慰剂更有效。然而，最佳的治疗时间仍然未知。 使用imatinib常见的副作用包括腹泻、疲倦、恶心、足背水肿、红血球数目下降、皮疹、呕吐与腹痛。 Imatinib在巴西、瑞士由诺华药厂制造，在2001年首次获得FDA核准上市。Imatinib是阻断导致肿瘤生长细胞连结分类药物的第一个。 | |
| FDA Approves Gleevec(Imatinib mesylate) for Gastrointestinal Stromal Tumor By Laurie Barclay, MD December 23, 2008 — On December 19, the US Food and Drug Administration (FDA) approved imatinib mesylate (Gleevec, Novartis) to prevent postoperative recurrence of gastrointestinal stromal tumor (GIST). "Approval of Gleevec offers health care professionals and patients an important new therapeutic option for patients with this uncommon gastrointestinal disease," said Richard Pazdur, MD, FDA director of Oncology Drug Products, Center for Drug Evaluation and Research, in a news release. "It illustrates how the continued study of a once novel drug throughout its product lifecycle can yield new and important uses." GIST is a rarely occurring cancer originating in the interstitial cells of Cajal, which are autonomic nervous system cells lining and regulating the movement of food and liquid through the stomach and intestines. Incidence of GIST in the United States is approximately 5000 to 6000 new diagnoses each year. Early diagnosis of GIST is hindered by the nonspecificity of symptoms such as nausea and vomiting. Although surgical resection is the first line of treatment, GIST frequently recurs. Imatinib is indicated postoperatively to help prevent the recurrence of GIST. A clinical trial showed that treatment with imatinib for 1 year after surgical removal of GIST was more effective than placebo in preventing tumor recurrence. However, optimal treatment duration is still unknown. Adverse reactions most frequently reported with imatinib were diarrhea, fatigue, nausea, pedal edema, decreased red blood cell counts, rash, vomiting, and abdominal pain. Imatinib, which is manufactured by Novartis AG in Basel, Switzerland, was first approved by the FDA in 2001. Imatinib was one of the first drugs in a class of agents blocking cellular communications leading to tumor growth. |
