登录  注册

肿瘤学学术中心

FDA批准ribociclib用于治疗HR+/HER2–晚期乳腺癌

FDA approves ribociclib for HR+, HER2– advanced breast cancer

发布者:Frontline Medical News 发布时间:2017-4-11

FDA已批准周期蛋白依赖性激酶(CDK)4/6抑制剂ribociclib联合芳香化酶抑制剂作为初始内分泌治疗,用于激素受体阳性/人类表皮生长因子受体阴性(HR+/HER2–)的晚期或转移性乳腺癌绝经后女性患者治疗。

The Food and Drug Administration has approved ribociclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

该批准是基于III期MONALEESA-2研究的研究结果:与接受安慰剂+来曲唑的334例患者相比,接受ribociclib+来曲唑的334例患者无进展生存期(PFS)得以改善(HR=0.556;95% CI,0.429~0.720;P<0.0001),但总生存期数据尚未得到。

Overall survival data is immature but approval was based on improvement in progression-free survival (PFS) among 334 women randomized to receive ribociclib plus letrozole compared to 334 women randomized to receive placebo plus letrozole in phase III MONALEESA-2 (hazard ratio, 0.556; 95% CI: 0.429, 0.720; P less than .0001).

FDA在书面声明中指出,ribociclib治疗组尚未到达预期的中位PFS,而安慰剂组PFS为14.7个月。Ribociclib治疗组的客观缓解率为52.7%(95% CI,46.6~58.9),安慰剂组为37.1%(95% CI,31.1~43.2)。

The estimated median PFS had not been reached in the ribociclib-containing arm and was 14.7 months in the placebo-containing arm. Objective response rate in patients with measurable disease was 52.7% (95% CI: 46.6, 58.9) in the ribociclib plus letrozole arm and 37.1% (95% CI: 31.1, 43.2) in the placebo plus letrozole arm, the FDA said in a written statement.

研究中,患者口服ribociclib 600 mg或安慰剂,每日一次,连续治疗21天,停药7天;同时口服来曲唑 2.5 mg,每日一次,连续治疗28天。所有患者均为HR+、HER2-的晚期或转移性乳腺癌绝经后初治患者,持续治疗至疾病进展或不可耐受。

Ribociclib 600 mg or placebo was administered orally once daily for 21 consecutive days, followed by 7 days off, with letrozole 2.5 mg administered orally once daily for 28 days. All patients were postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer who received no prior therapy for advanced disease. Treatment continued until disease progression or unacceptable toxicity,

Ribociclib最常见的不良反应包括:中性粒细胞减少症、恶心、乏力、腹泻、白细胞减少症、脱发、呕吐、便秘、头疼以及背痛。最常见的3级或4级不良反应包括:中性粒细胞减少症、白细胞减少症、肝功能异常、淋巴细胞减少以及呕吐。FDA警告指出,ribociclib还可剂量依赖性地延长QT间期。

The most common adverse reactions in patients taking ribociclib were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain. The most common grade 3 or 4 adverse reactions were neutropenia, leukopenia, abnormal liver function tests, lymphopenia, and vomiting. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner, the FDA warns.

Ribociclib是第2个获准治疗晚期乳腺癌的CDK4/6抑制剂。2015年,palbociclib(Ibrance)联合来曲唑(弗隆)作为绝经后ER+/HER2-转移性乳腺癌患者的一线治疗药物获得加速批准。2016年,FDA扩大了氟维司群(fulvestrant)的适应证,用于palbociclib联合治疗。

Ribociclib is the second CDK4/6 inhibitor to receive approval for advanced breast cancer, following the accelerated approval of palbociclib(Ibrance) plus letrozole(Femara) as a first-line treatment for postmenopausal women with ER-postive, HER2-negative metastatic breast cancer in 2015. The FDA expanded the indication for fulvestrant to include use in combination with palbociclib in 2016.

在2016年ASCO年会上报告的II期临床数据显示,第3个CDK4/6抑制剂abemaciclib对此类患者也具疗效。

Phase II trial data indicating activity of a third CDK 4/6 inhibitor, abemaciclib, in this patient population was presented at the 2016 ASCO Annual Meeting.

Ribociclib推荐的起始剂量为600 mg(200 mg/片,3片),口服,每日一次,与食物同服与否均可,连续治疗21天,停药7天。

The recommended starting dose of ribociclib is 600 mg orally (three 200-mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment.

Ribociclib将由诺华制药公司以商品名Kisqali上市销售。

Ribociclib is being marketed as Kisqali by Novartis Pharmaceuticals Corp.

独家授权,未经许可请勿转载!

顶一下(0
来源: Frontline Medical News

发表评论

学科影响因子排名more

 会议回顾 more

  • 【专题】2015年美国临床肿瘤大会...

  • 多模式防治 改善肿瘤患者生存

  • 第13届St. Gallen国际乳...

 热门病例 more

 热门指南  more

Elsevier中国网站
爱唯医学网
爱思唯尔科技部
NursingChina
柳叶刀中文版
大通医疗决策
医大爱思唯尔
Elsevier医学数据库
CK
Journal Consult
Procedures_CONSULT
ClinicalPharmacologyLogo
3D Interact Anatomy
Mosby’s Nursing Consult
NursingChina
Science Direct