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IBRANCE(palbociclib capsules)

2015-02-07 10:47:42  作者:新特药房  来源:互联网  浏览次数:695  文字大小:【】【】【
简介: 第一个乳腺癌免疫治疗药物Ibrance(palbociclib)胶囊剂被美国FDA加速批准批准日期:2015年2月 公司:辉瑞 PfizerFDA药品评价和研究中心血液学和肿瘤产品室主任Richard Pazdur医学博士说:“palbocicli ...

第一个乳腺癌免疫治疗药物Ibrance(palbociclib)胶囊剂被美国FDA加速批准
批准日期:
2015年2月 公司:辉瑞 Pfizer
FDA药品评价和研究中心血液学和肿瘤产品室主任Richard Pazdur医学博士说:“palbociclib添加至来曲唑对被诊断有转移乳癌妇女提供一种新颖治疗选择,”“FDA承诺通过我们的加快批准监管加快癌症药物的上市批准。”
IBRANCE(palbociclib胶)囊剂,供口服使用
美国最初批准:2015年
适应症和用法
IBRANCE是组合表示与来曲唑治疗绝经后妇女的雌激素受体(ER)阳性,人表皮生长因子受体2(HER2)阴性晚期乳腺癌作为初始内分泌为基础的治疗对于其转移性疾病治疗中的激酶抑制剂。 (1)这个指示下基于无进展生存期(PFS)加速审批核准。继续批准该适应症可能是在验证和临床获益说明队伍的验证试验。
【用法用量】
IBRANCE胶囊口服与食物中来曲唑的组合。
推荐起始剂量:125毫克,每天一次与食物一起服用21天,随后7天假治疗。
中断给药和/或减量是基于个人的安全性和耐受性建议。
剂型和规格
胶囊:125毫克,100毫克和75毫克。
禁忌

警告和注意事项
血液系统:白细胞减少,可能会发生。监测全血细胞计数前两个周期的开始IBRANCE疗法中,并在每个周期的开始之前,以及在第14天,并作为临床指征。
感染:用于监控的症状和体征,并扣留剂量适当。
胚胎胎儿毒性:可引起胎儿造成伤害。提醒潜在风险的患者胎儿,并使用有效的避孕措施。
不良反应
最常见的不良反应(发生率≥10%)为白细胞减少,白细胞减少,乏力,贫血,上呼吸道感染,恶心,口腔炎,脱发,腹泻,血小板减少症,食欲下降,呕吐,无力,周围神经病变,和鼻出血。
要报告疑似不良反应,请联系辉瑞公司在1-800-438-1985或FDA在1-800-FDA-1088或www.fda.gov/medwatch
药物相互作用
CYP3A抑制剂:避免同时使用IBRANCE具有较强CYP3A酶抑制剂。如果不能避免的强抑制剂,降低IBRANCE剂量。
CYP3A诱导剂:避免同时使用IBRANCE具有较强的和中度CYP3A诱导剂。
CYP3A的底物:敏感CYP3A4底物具有窄治疗指数的剂量可能需要降低与IBRANCE同时给予时。


Ibrance (palbociclib)
Company: Pfizer
Approval Status: Approved February 2015
Treatment for: ER-positive, HER2-negative breast cancer
Areas: Pregnancy & Gynecology; Cancer & Oncology
General Information
Ibrance (palbociclib) is an orally available pyridopyrimidine-derived cyclin-dependent kinase (CDK) inhibitor with antineoplastic activity.
Ibrance is specifically indicated for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Ibrance is supplied as a capsule for oral administration. The recommended dose of Ibrance is a 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Ibrance should be taken with food in combination with letrozole 2.5 mg once daily given continuously throughout the 28-day cycle. The dose should be taken at approximately the same time each day.
If the patient vomits or misses a dose, an additional dose should not be taken that day. The next prescribed dose should be taken at the usual time. Ibrance capsules should be swallowed whole (do not chew, crush or open them prior to swallowing). No capsule should be ingested if it is broken, cracked, or otherwise not intact.
Please see the drug label for recommended dose modifications based on adverse events.
Clinical Results
FDA Approval
The FDA approval of Ibrance was based on  a randomized, open-label, multicenter study of Ibrance plus letrozole versus letrozole alone conducted in 165 postmenopausal women with ER-positive, HER2-negative advanced breast cancer who had not received previous systemic treatment for their advanced disease. Randomization was stratified by disease site (visceral versus bone only versus other) and by disease-free interval (>12 months from the end of adjuvant treatment to disease recurrence versus ≤12 months from the end of adjuvant treatment to disease recurrence or de novo advanced disease). Ibrance was given orally at a dose of 125 mg daily for 21 consecutive days followed by 7 days off treatment. Subjects received study treatment until progressive disease, unmanageable toxicity, or consent withdrawal. For subjects treated with the combination of Ibrance plus letrozole, the median PFS was 20.2 months compared to the 10.2 months of PFS in subjectswho received letrozole alone. Overall response rate in subjects with measurable disease as assessed by the investigator was higher in the Ibrance plus letrozole compared to the letrozole alone arm (55.4% versus 39.4%).
Side Effects
Adverse effects associated with the use if Ibrance may include, but are not limited to, the following:
neutropenia
leukopenia
fatigue
anemia
upper respiratory infection
nausea
stomatitis
alopecia
diarrhea
thrombocytopenia
decreased appetite
vomiting
asthenia
peripheral neuropathy
epistaxis
Mechanism of Action
Ibrance (palbociclib) is an inhibitor of cyclin-dependent kinase (CDK) 4 and 6. Cyclin D1 and CDK4/6 are downstream of signaling pathways which lead to cellular proliferation. In vitro, palbociclib reduced cellular proliferation of estrogen receptor (ER)-positive breast cancer cell lines by blocking progression of the cell from G1 into S phase of the cell cycle. Treatment of breast cancer cell lines with the combination of palbociclib and antiestrogens leads to decreased retinoblastoma protein (Rb) phosphorylation resulting in reduced E2F expression and signaling and increased growth arrest compared to treatment with each drug alone. In vitro treatment of ER-positive breast cancer cell lines with the combination of palbociclib and antiestrogens leads to increased cell senescence, which was sustained for up to 6 days following drug removal. In vivo studies using a patient-derived ER-positive breast cancer xenograft model demonstrated that the combination of palbociclib and letrozole increased the inhibition of Rb phosphorylation, downstream signaling and tumor growth compared to each drug alone.

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