FDA批准的第一个用于治疗非小细胞癌的口服药托泊替康

bitsweet · 发表于 2007-10-24 09:33:53

First oral drug approved for small cell lung cancer Source: (cancerfacts.com) Monday, October 15, 2007

HILADELPHIA – Oct. 15, 2007– GlaxoSmithKline announced today approval by the U.S. FDA for oral HYCAMTIN® (topotecan) capsules for the treatment of relapsed small cell lung cancer (SCLC). <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">Specifically, HYCAMTIN capsules are indicated for patients who had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment. HYCAMTIN capsules are the only oral single-agent chemotherapy approved for the treatment of SCLC after failure of first-line therapy. The product will be available in 2008. <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">"The approval of HYCAMTIN capsules is particularly important for patients with relapsed small cell lung cancer as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home," said Dr. Debasish Roychowdhury, vice president, Global Clinical Development, Oncology at GSK. "Additionally, this milestone underscores GSK Oncology's commitment to helping improve cancer patients' quality of life." <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">This approval was based on positive results from a large comparison study of HYCAMTIN capsules plus best supportive care (BSC) to BSC alone in patients with relapsed SCLC, in addition to earlier smaller supporting studies. Best supportive care refers to treatments intended to control, prevent and relieve disease complications to improve comfort and quality of life for the patient, but are not intended to have any anti-tumor effects. <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">In the large multicenter trial, 70 patients with relapsed SCLC who were not considered candidates for standard intravenous therapy were randomly assigned to receive BSC alone and 71 were assigned to receive HYCAMTIN capsules plus BSC. <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">The primary objective was to compare overall survival between the two treatment arms. Patients who received HYCAMTIN capsules plus BSC showed a statistically significant improvement in overall survival compared with the patients who received BSC alone. <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">Median survival with HYCAMTIN capsules plus BSC was 25.9 weeks compared to 13.9 weeks for those given BSC alone. This represents a 36 percent reduction in the risk of death for patients who received HYCAMTIN capsules plus BSC compared with the patients who received BSC alone. The results were published in the Dec. 1, 2006 issue of the Journal of Clinical Oncology.   <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">"In clinical trials, HYCAMTIN capsules have shown the potential to benefit patients with small cell lung cancer, many of whom are prone to relapse," said Dr. John Eckardt, director of clinical research for the Center for Cancer Care and Research, St. Louis, MO. "The approval of HYCAMTIN capsules opens up new possibilities for patients battling this disease and provides a convenient alternative to IV therapy." <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">The most common severe or life-threatening side effects involved the immune and blood systems with HYCAMTIN capsules linked to a severe or life-threatening loss of infection-fighting white cells (neutropenia) occurring in 61% of those treated, while 37 percent suffered severe loss of blood-clotting platelet cells and 25 percent experienced a severe or greater loss of red blood cells (anemia). The most common (>10%) non-hematologic adverse reactions (all grades) were nausea (27%), diarrhea (14%), vomiting (19%), fatigue (11%) and alopecia (10%).(2) <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">SCLC is caused by an uncontrolled growth of cells beginning on the surface of the lung's breathing tubes (called bronchi) and tends to spread widely through the body. This is important because it means that surgery is rarely used as a treatment option. Chemotherapy is the most common treatment for SCLC. Although SCLC is often responsive to first-line treatments, patients may relapse. <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">SCLC is most common in current or past smokers, but can also be caused by environmental risk factors such as exposure to radon and air pollution. About 15% of patients with lung cancer have SCLC, a fast-growing form of the disease. <span lang="EN-US" style="FONT-SIZE: 10.5pt; BACKGROUND: white; COLOR: black; FONT-FAMILY: Verdana; mso-bidi-font-size: 12.0pt; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;"> <span lang="EN-US" style="FONT-SIZE: 12pt; FONT-FAMILY: Verdana; mso-fareast-font-family: 宋体; mso-font-kerning: 1.0pt; mso-bidi-font-family: "Times New Roman"; mso-ansi-language: EN-US; mso-fareast-language: ZH-CN; mso-bidi-language: AR-SA;">SOURCE: Adapted from press release by GlaxoSmithKline: Reference: O'Brien MER, Ciuleanu T-E, Tsekov H et al. Phase III Trial Comparing Supportive Care Alone with Supportive Care with Oral Topotecan in Patients with Relapsed Small-cell Lung Cancer.

爱狗狗呦 · 发表于 2007-11-20 16:43:35

应该是小细胞肺癌吧？少了一个“N”，是“SCLC”，一字之差，差之千里。<h1>葛兰素史克的托泊替康(topotecan，Hycamtin)有望获得欧盟上市许</h1><div class="adwright"></div>近日，人用医疗产品委员会(Committee for Medicinal Products for Human Use)的专家建议欧盟批准葛兰素史克公司(GlaxoSmithKline)的抗癌药物托泊替康(topotecan，Hycamtin)上市。专家们是考察了不适合再次接受一线药物治疗方案的患者情况后提出以上建议的。小细胞肺癌患病人数占肺癌总数的15～18%。Hycamtin是一种注射用化疗药物，属于拓扑异构酶抑制剂Ⅰ抑制剂。一般而言，欧盟会在90天内通过人用医疗产品委员会提交的上市许可建议。

以马内利 · 发表于 2007-11-20 17:27:40

爱狗狗呦真是心细，我英文不是很好，但看得出来是小细胞肺癌，可能是楼主笔误了。葛兰素史克是国际大药厂，但是对于托泊替康的信息还很少，大家如果有这方面的资讯也欢迎跟帖。

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