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 晚期乳腺癌 出现新药了 有兴趣的朋友可以看看


FDA NEWS RELEASE
For Immediate Release: Nov. 15, 2010
Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves new treatment option for late-stage breast cancer

The U.S. Food and Drug Administration today approved Halaven (eribulin mesylate) to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,090 women will be diagnosed with breast cancer, while 39,840 women will die from the disease.

Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

Halaven’s safety and effectiveness were established in a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. Patients were randomly assigned to receive treatment with either Halaven or a different single agent therapy chosen by their oncologist.

The study was designed to measure the length of time from when this treatment started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.

“There are limited treatment options for women with aggressive forms of late-stage breast cancer who have already received other therapies,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. "Halaven shows a clear survival benefit and is an important new option for women."

The most common side effects reported by women treated with Halaven include a decrease in infection-fighting white blood cells (neutropenia), anemia, a decrease in the number of white blood cells (leukopenia), hair loss (alopecia), fatigue, nausea, weakness (asthenia), nerve damage (peripheral neuropathy), and constipation.

Other FDA-approved therapies used to treat late-stage, refractory breast cancer include Xeloda (capecitabine) for patients with breast cancer resistant to paclitaxel and anthracycline-containing chemotherapy; Ixempra (ixabepilone) for patients with late-stage disease after failure of an anthracycline, taxane and Xeloda; and Ixempra plus Xeloda for patients with late-stage disease after failure of anthracycline- and taxane-based chemotherapy.

Halaven is marketed by Woodcliff Lakes, N.J. -based Eisai Inc.

[楼 主] | Posted:10-11-16 08:48| 顶端
oupeng


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有中文的吗?


收入与付出是成正比的!
[1 楼] | Posted:11-06-03 15:45| 顶端
yycwm




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这是我查的译文,准否自己把握

食品及药物管理局新闻发布
立即发布:2010年11月15日
媒体调查:Erica Jefferson,301-796-4988,爱奥斯。杰弗里斯@fda.hhs.gov。
消费者调查:888 -信息- fda
FDA批准晚期乳腺癌的新治疗方案
美国食品和药物管理局今天批准了Halaven(eribulat mesy晚期)治疗转移性乳腺癌患者,他们已经接受了至少两种治疗晚期疾病的化疗方案。
据美国国家癌症研究所称,乳腺癌是导致女性癌症死亡的第二大原因。今年,估计有207090名女性将被诊断为乳腺癌,而39840名妇女将死于乳腺癌。
Halaven是一种合成的化学疗法,是由海海绵状的海棉球类的海棉球衍生而来的。这种注射疗法是一种微管抑制剂,被认为是通过抑制癌细胞生长而起作用的。在接受Halaven之前,患者应该接受之前的蒽环霉素和基于紫杉碱的化疗,用于早期或晚期乳腺癌。
Halaven的安全性和有效性是在762名患有转移性乳腺癌的女性中建立的,他们已经接受了至少两种治疗晚期疾病的化疗方案。病人被随机分配接受治疗,要么是Halaven,要么是由肿瘤医生选择的不同的单一药物治疗。
这项研究的目的是测量从治疗开始到病人死亡(总体生存率)的时间长度。接受Halaven治疗的患者的平均生存期为13.1个月,而接受单一药物治疗的患者的平均寿命为10.6个月。
Richard Pazdur说:“对于那些患有晚期乳腺癌的女性来说,治疗方法有限,她们已经接受了其他治疗。”他是FDA药物评估和研究中心肿瘤药物产品办公室主任。“Halaven为女性提供了一个明确的生存利益,也是一个重要的新选择。”
女性治疗的最常见副作用包括抗感染白血球减少(中性白血球减少),贫血,白血球减少(白血球减少),脱发(脱发),疲劳,恶心,虚弱(虚弱无力),神经损伤(周围神经病变)和便秘。
其他fda批准的用于治疗晚期、难治性乳腺癌的治疗方法包括Xeloda(capecitabine),用于治疗对紫杉烷和蒽类化疗有耐药性的乳腺癌患者;在一种蒽环素、紫杉烷和Xeloda的失败后,对晚期疾病患者的Ixempra(ixabepilone);Ixempra和Xeloda对晚期疾病的患者进行了治疗,这是在蒽环素和基于紫杉碱的化疗之后。
Halaven是由位于新泽西州伍德克利夫湖的卫材公司销售的。



yycwm
[2 楼] | Posted:17-12-29 12:13| 顶端

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