近日,乳腺癌新药BRANCE已获得美国食品药品监督管理局FDA的加速批准。 IBRANCE是一种口服细胞周期素依赖性激酶4和6抑制剂，其与来曲唑联合使用可作为内分泌治疗基础的初始方案用于治疗ER+/HER2-绝经后晚期乳腺癌。
IBRANCE是基于2期临床试验PALOMA-1研究最终结果提交的新药申请。 据了解，该试验达到了其主要研究重点，证实了IBRANCE联合来曲唑治疗ER+/HER2-初治的局部晚期或转移性乳腺癌患者较单药来曲唑延长了患者PFS。
FDA 药品评价和研究中心血液学和肿瘤产品室主任说：“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。”
批准日期：2015年2月3日；公司：Pfizer Inc.
IBRANCE®(palbociclib)胶囊口服说明
美国初次批准：2015
适应证和用途
IBRANCE是一个激酶抑制剂适用与来曲唑联用为有雌激素受体(ER)-阳性，人表皮生长因子受体2(HER2)-阴性晚期乳癌绝经后妇女的治疗作为初始基于内分泌治疗对其转移疾病。这个适应证是根据无进展生存(PFS)在加速批准下被批准。剂型批准此适应证可能取决于在验证性试验中临床获益的证明和描述。
剂量和给药方法
IBRANCE胶囊是与食物与来曲唑联用口服。
⑴推荐开始剂量：125 mg每天一次与食物服用共21天接着7天不治疗。
⑵建议根据个体安全性和耐受性中断和/或剂量减低给药。
剂型和规格
胶囊：125mg，100mg,和75mg
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IBRANCE safely and effectively. See full prescribing information for IBRANCE.
IBRANCE ® (palbociclib) capsules, for oral use
Initial U.S. Approval: 2015
INDICATIONS AND USAGE
IBRANCE is a kinase inhibitor indicated 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. (1) 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. (14)
DOSAGE AND ADMINISTRATION
IBRANCE capsules are taken orally with food in combination with letrozole. (2)
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Recommended starting dose: 125 mg once daily taken with food for 21 days followed by 7 days off treatment. (2.1)
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Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. (2.2)
DOSAGE FORMS AND STRENGTHS
Capsules: 125 mg, 100 mg, and 75 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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Hematologic: Neutropenia may occur. Monitor complete blood count prior to start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 14 of the first two cycles, and as clinically indicated. (5.1)
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Infections: Monitor for signs and symptoms and withhold dosing as appropriate. (5.2)
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Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. (5.4, 8.1, 8.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥10%) were neutropenia, leukopenia, fatigue, anemia, upper respiratory infection, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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CYP3A Inhibitors: Avoid concurrent use of IBRANCE with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the IBRANCE dose. (2.2, 7.1)
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CYP3A Inducers: Avoid concurrent use of IBRANCE with strong and moderate CYP3A inducers. (7.2)
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CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with IBRANCE. (7.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 2/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
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