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FDA加速批准晚期软组织肉瘤新药

FDA grants accelerated approval to new treatment for advanced soft tissue sarcoma

发布者:FDA 发布时间:2016-11-4

The U.S. Food and Drug Administration today granted accelerated approval to Lartruvo (olaratumab) with doxorubicin to treat adults with soft tissue sarcoma (STS) who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.

美国FDA今日加速批准了Lartruvo (olaratumab)与多柔比星,联合用于不能接受放疗和手术治疗,但适合蒽环类化疗的成人软组织肉瘤(STS)患者之治疗。

 “For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence. “This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin’s approval more than 40 years ago.”

FDA药品评价与研究中心血液与肿瘤产品办公室主任兼肿瘤卓越研究中心代理主任Richard Pazdur博士称:Lartruvo联合多柔比星,为这些患者提供了新的治疗选择。这是多柔比星上市40多年后,FDA批准的首个STS初始治疗新药。

Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. When stimulated, PDGF receptors cause tumor growth. Lartruvo works by blocking these receptors, which may help slow or stop tumor growth.

Lartruvo是血小板衍化生长因子(PDGF)受体α阻断性抗体。PDGF受体一旦受到刺激,可促使肿瘤生长。Lartruvo通过阻断这些受体,有助于减缓或阻止肿瘤生长。

The safety and efficacy of Lartruvo were studied in a randomized clinical trial involving 133 patients with more than 25 different subtypes of metastatic STS. Patients received either Lartruvo with doxorubicin or doxorubicin alone. Compared to patients who received doxorubicin alone,patients who received Lartruvo with doxorubicin had a statistically significant improvement in the median overall survival(26.5 months vs. 14.7 months), the median progression-free survival(8.2 months vs. 4.4 months) and the overall response rate(8.2 % vs. 7.5%).

在一项纳入133例、涉及25种以上不同亚型转移性STS患者的随机临床试验中,评价了Lartruvo的安全性和有效性。患者接受Lartruvo+多柔比星或单纯多柔比星治疗。相较于只以多柔比星治疗的患者,接受Lartruvo+多柔比星治疗的患者其中位总生存期(26.5个月 vs. 14.7个月)、中位无进展生存期(8.2个月 vs. 4.4个月)和总应答率(18.2% vs. 7.5%)均有统计学意义显著改善。

Lartruvo has serious risks including infusion-related reactions and embryo-fetal harm. Infusion-related reactions include low blood pressure, fever, chills and rash. The most common side effects of treatment with Lartruvo are nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy and headache.

Lartruvo可导致包括输注相关反应和胚胎-胎儿损害等严重风险。输注相关反应包括低血压、发热、发冷和皮疹。最常见的副作用包括恶心、疲乏、嗜中性白细胞减少症、肌肉骨骼痛、粘膜炎、脱发、呕吐、腹泻、食欲下降、腹痛、神经疾病以及头疼。

The FDA granted the Lartruvo application fast track designation, breakthrough therapy designation and priority review status. Lartruvo also received orphan drug designation. The FDA is approving Lartruvo under the agency’s accelerated approval program.

FDA授予Lartruvo申请快速通道资格、突破治疗认定和优先审评资格。Lartruvo还获得孤儿药资格认定。FDA按照加速批准程序批准Lartruvo。

The sponsor is conducting a larger study, which is currently underway, to further explore the effectiveness of Lartruvo across the multiple subtypes of STS.

申请人正在开展一项大规模研究,以进一步探索Lartruvo用于多种STS亚型 的有效性。

Lartruvo is marketed by Eli Lilly and Company based in Indianapolis, Indiana.

Lartruvo由位于印第安纳州印第安纳波利斯的礼来制药公司上市销售。

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来源: FDA

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