FDA批准tbo-filgrastim用于化疗相关中性粒细胞减少症

圣路易斯(MD Consult)——2012年8月30日，梯瓦制药和美国食品药品管理局(FDA)宣布，已批准tbo-filgrastim(XM02 filgrastim)用于因接受化疗而导致中性粒细胞减少症的非骨髓恶性肿瘤患者，以减少严重中性粒细胞减少症的持续时间。Tbo-filgrastim是一种短效重组粒细胞集落刺激因子(G-CSF)。

一项纳入348例正在接受阿霉素和多西他赛治疗的晚期乳腺癌患者的临床研究对tbo-filgrastim的有效性进行了评价。患者被随机分组，接受tbo-filgrastim、美国未批准的filgrastim制剂或安慰剂治疗，tbo-filgrastim治疗组严重中性粒细胞减少症恢复时间为1.1天，而安慰剂组为3.8天。

共纳入680例接受大剂量骨髓抑制性化疗的乳腺癌、肺癌或非霍奇金淋巴瘤患者的三项临床研究评价了Tbo-filgrastim的安全性。接受tbo-filgrastim治疗者的最常见不良反应为骨痛。

接受tbo-filgrastim治疗可能出现的严重不良事件包括脾破裂、急性呼吸窘迫综合征、过敏反应以及镰状红细胞病患者镰状红细胞危象。

Tbo-filgrastim在化疗24 h后开始应用。该产品为皮下注射剂，其上市规格为300 μg/0.5 ml和480 μg/0.8 ml的单剂、不含防腐剂的预填充注射剂。梯瓦公司计划最早将从2013年11月开始销售tbo-filgrastim。

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ST LOUIS (MD Consult) - On August 30, 2012, Teva Pharmaceuticals and the US Food and Drug Administration (FDA) announced the approval of tbo-filgrastim (XM02 filgrastim), indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies who are receiving chemotherapy that adversely affects the production of neutrophils by the bone marrow. Tbo-filgrastim is a short-acting recombinant form of granulocyte colony-stimulating factor (G-CSF).

Tbo-filgrastim was evaluated in a clinical study of 348 adult patients with advanced breast cancer who were receiving treatment with doxorubicin and docetaxel. Patients were randomly assigned to receive tbo-filgrastim, a placebo, or a non-US-approved filgrastim product. Patients who received tbo-filgrastim recovered from severe neutropenia in 1.1 days compared with 3.8 days in patients who received the placebo.

Tbo-filgrastim's safety was evaluated in 3 clinical studies that included 680 adults with breast cancer, lung cancer, or non-Hodgkin's lymphoma who received high-dose myeloablative chemotherapy. The most common adverse effect observed in patients who received tbo-filgrastim was bone pain.

Serious adverse events that may occur with the use of tbo-filgrastim include splenic rupture, acute respiratory distress syndrome, allergic reactions, and sickle-cell crisis in patients with sickle cell disease.

Tbo-filgrastim is administered beginning 24 hours after chemotherapy treatment. The product is a solution for subcutaneous injection, and will be supplied as a single-use, preservative-free, prefilled-syringe in doses of 300 μg/0.5mL and 480 μg/0.8mL. Teva plans to market tbo-filgrastim as early as November 2013.