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Jevtana(cabazitaxel)注射剂

ID号：676 发布日期： 2013-08-28 截止日期：不限地区：全国浏览次数：43

药品名称：卡巴他赛及其注射液
规格：60mg/1.5ml、40mg/ml
适应症：
JEVTANA是一种微管抑制剂适用于与泼尼松联用治疗既往用含多烯紫杉醇治疗方案激素难治转移性前列腺癌患者
药品介绍：
前列腺癌是男性常见恶性肿瘤，常发病于老年男性，在美国是除在皮肤癌之外第二大常见男性癌症。据疾病防控中心最近统计报道，2006年约有203415名男性罹患前列腺癌，其中28372人死亡。Jevtana的上市，患者更多的治疗机会。Jevtana
前列腺癌是男性常见恶性肿瘤，常发病于老年男性，在美国是除在皮肤癌之外第二大常见男性癌症。据疾病防控中心最近统计报道，2006年约有203415名男性罹患前列腺癌，其中28372人死亡。Jevtana的上市，患者更多的治疗机会。Jevtana(cabazitaxel)因其疗效卓越而在2010年获FDA优先审核批准上市，用于对多烯紫杉醇无效甚至病情加重的晚期前列腺癌患者，首选的用于治疗晚期、抗激素型前列腺癌的药物。Jevtana（cabazitaxel）注射液经美国FDA优先审评后获得批准－转移性激素难治性前列腺癌的二线治疗中首个及唯一一个提供显著生存获益的治疗药物。Jevtana（cabazitaxel）注射液用于与泼尼松联合治疗既往接受过含多西他赛方案治疗的转移性激素难治性前列腺癌（mHRPC）患者。
Jevtana(cabazitaxel)因其疗效卓越而获FDA优先审核批准上市，用于对多烯紫杉醇无效甚至病情加重的晚期前列腺癌患者，首选的用于治疗晚期、抗激素型前列腺癌的药物。Jevtana（cabazitaxel）注射液经美国FDA优先审评后获得批准－转移性激素难治性前列腺癌的二线治疗中首个及唯一一个提供显著生存获益的治疗药物。Jevtana（cabazitaxel）注射液用于与泼尼松联合治疗既往接受过含多西他赛方案治疗的转移性激素难治性前列腺癌（mHRPC）患者。
赛诺菲安万特 Jevtana (cabazitaxel) 获FDA批准为晚期前列腺癌患者带来福音
6月17日，美国食品和药物管理局（FDA）批准化疗药物Jevtana（cabazitaxel）联合类固醇泼尼松治疗男性前列腺癌。Jevtana是晚期的、激素难治性、多西他赛治疗期间或之后恶化的前列腺癌的首选药物。多西他赛常用于晚期前列腺癌的治疗。
对于前列腺癌患者，雄激素睾酮可以导致前列腺肿瘤的生长。药物、手术或其他激素用于减少睾酮产生或阻止它。对于有些患激素难治性前列腺癌的男性，意味着尽管睾酮被抑制，但前列腺癌细胞继续生长。该类型的癌症患者需要不同的治疗方法。
根据FDA的优先评审方案（其为可能会提供重大进展的药物或在无足够治疗时提供的一种治疗而提供的快速的6个月评审），Jevtana得到了优先评审。 Jevtana的获准日期早于其原计划的目标日期2010年9月30日。
“这种疾病患者的治疗选择很少，”FDA的药物评价和研究中心的肿瘤药物产品办公室主任Richard Pazdur博士说。“美国FDA能够在11个星期内对Jevtana进行评审和批准，这加快了这一药物对前列腺癌男性供应。”
在一项纳入755例患者的研究中确立了Jevtana的安全性和有效性。所有受试者曾接受多西他赛治疗。这项研究旨在研究比较接受Jevtana联合泼尼松的患者与那些接受化疗药物米托蒽醌联合泼尼松患者之间的总体生存期（即死亡前的时间）。接收Jevtana方案的患者的中位总体生存期为15.1月，而那些接手米托蒽醌方案的患者的中位总体生存期为12.7月。
接受Jevtana治疗的患者出现的副作用，包括抗感染白细胞减少（中性粒细胞减少）、贫血、白细胞（白细胞减少）、低水平的血小板（血小板减少）、腹泻、疲劳、恶心、呕吐、便秘、虚弱（乏力）和肾功能衰竭。
前列腺癌通常见于老年男性，在美国男性中其是第二个最常见的癌症，位居皮肤癌之后。根据美国疾病控制和预防中心，2006年有203415名男性罹患前列腺癌和28372例男性死于该种疾病。
Jevtana由赛诺菲安万特推出。
Manufacturer:
Sanofi-aventis
Pharmacological Class:
Antineoplastic (taxane antimicrotubule agent).
Active Ingredient(s):
Cabazitaxel 60mg/1.5mL; soln for IV infusion after dilution; contains polysorbate 80, diluent contains ethanol.
Indication(s):
In combination with prednisone, hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen.
Pharmacology:
Cabazitaxel is a semisynthetic taxane antineoplastic agent prepared from an extract of yew needles. Cabazitaxel is a microtubule inhibitor that binds to tubulin and promotes its assembly into microtubules while simultaneously inhibiting disassembly. This leads to the stabilization of microtubules, which results in the inhibition of mitotic and interphase cellular functions. It has been shown to have activity in tumor models that were insensitive to docetaxel chemotherapy as well as in those that were docetaxel-sensitive.
Cabazitaxel is extensively metabolized by the liver, and it is not recommended for use in patients with impaired hepatic function due to a probable increase in cabazitaxel levels and toxicity.
Clinical Trials:
Cabazitaxel was compared to mitoxantrone in a multicenter, randomized, open-label study in 755 patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. Patients were randomized to receive either cabazitaxel (25mg/m2 every 3 weeks for up to 10 cycles with prednisone 10mg daily) or mitoxantrone (12mg/m2 every 3 weeks for up to 10 cycles with prednisone 10mg daily). Patients with hepatic impairment, hypertension, and certain cardiac conditions were excluded from the trial.
In an intent-to-treat analysis, the median survival time for the cabazitaxel group was 15.1 months, compared to 12.7 months for mitoxantrone; 61.9% of the patients in the cabazitaxel group died by the 30th month, compared to 74% in the mitoxantrone arm. The investigator-assessed tumor response was higher in the cabazitaxel group (14.4%) compared to the mitoxantrone group (4.4%).
Legal Classification:
Rx
Adults:
Pretreat with IV antihistamine, corticosteroid, and H2 blocker 30 min before each dose (see literature) and with antiemetic (IV or oral as needed). 25mg/m2 by IV infusion over 1 hour every 3 weeks, with oral prednisone 10mg/day during treatment. Do not treat if neutrophil count ≤1,500 cells/mm3. Prolonged grade ≥3 neutropenia (>1 week), febrile neutropenia, grade ≥3 diarrhea: delay treatment and/or reduce dose to 20mg/m2 (see literature). Discontinue if reactions persist after dosing at 20mg/m2.
Children:
Not recommended.
Contraindication(s):
Baseline neutrophil count ≤1,500cells/mm3. Allergy to polysorbate 80.
Warnings/Precautions:
Do CBC weekly in 1st cycle and before each subsequent cycle. Increased risk of neutropenia complications; consider G-CSF prophylaxis. Hepatic impairment: not recommended. Severe renal impairment (CrCl <30mL/min) or ESRD. Elderly (increased susceptibility to adverse reactions); monitor closely. Pregnancy (Cat.D; avoid). Nursing mothers: not recommended.
Interaction(s):
Avoid strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, atazanavir, nefazodone, nelfinavir, ritonavir, saquinavir, voriconazole) (may potentiate cabazitaxel); caution with moderate CYP3A4 inhibitors. Avoid strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, phenobarbital) (may antagonize cabazitaxel). Avoid St. John’s Wort.
Adverse Reaction(s):
Bone marrow suppression (esp. neutropenia, anemia, leukopenia, thrombocytopenia), febrile neutropenia, GI upset (esp. diarrhea, may be fatal), renal failure, fatigue, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, alopecia, hypersensitivity reactions (eg, rash, hypotension, bronchospasm).
How Supplied:
Kit (single-use vial + diluent)—1
Last Updated:
9/2/2010