2017年10月9日，FDA批准晚期或转移性乳腺癌药物verzenio新药上市。该药物用于内分泌治疗后病情进一步发展了的HR阳性、HER2阴性患者。Verzenio被批准与内分泌疗法药物fulvestrant结合，共同治疗内分泌治疗后病情进一步发展的患者；同时，verzenio也被批准单独用于内分泌治疗和化疗无法控制的晚期或转移性乳腺癌患者。 FDA药物评估与研究中心的血液和肿瘤产品办公室主任、FDA肿瘤中心主任Richard Pazdur博士说：“Verzenio为某些患有乳腺癌的患者提供了一种新的有针对性的治疗方案，不像其他经典的治疗药物，verzenio可以作为一种独立的治疗方法，对以前接受过内分泌治疗和化疗的患者进行治疗。” Verzenio的作用原理是阻断4型和6型细胞周期依赖性激酶（CDK），抑制癌细胞的生长。与verzenio具有相似作用原理的还有两种药物palbociclib和ribociclib分别于2015年2月和2017年3月获得批准。 乳腺癌是美国最常见的癌症。美国国立卫生研究院的国家癌症研究所估计，今年将有大约25.2万名女性被诊断为乳腺癌，4万多名女性将死于乳腺癌。大约72%乳腺癌患者的肿瘤为HR阳性和HER阴性。 在探讨verzenio与fulvestrant联合疗法的安全性和有效性的试验中，共涉及669名乳腺癌患者，其中包括了内分泌治疗的HER2阴性的乳腺癌患者以及在癌症发生转移后未接受化疗的患者。该项研究检测了治疗后肿瘤的无进展生存率。服用verzenio治疗的平均无进展生存率为16.4个月，而服用安慰剂的患者为9.3个月。 Verzenio (abemaciclib) Tablets VERZENIO Rx Generic Name and Formulations: Abemaciclib 50mg, 100mg, 150mg, 200mg; tabs. Company: Lilly, Eli and Company Monograph added. Indications for VERZENIO: In combination with fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy. As monotherapy for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. Adult: Swallow whole. Take at the same time every day. Combination with fulvestrant (see full labeling): initially 150mg twice daily; in pre/perimenopausal women: also treat with a gonadotropin-releasing hormone agonist according to current practice standards. Monotherapy: initially 200mg twice daily. Both: continue until disease progression or unacceptable toxicity. Dose modifications for adverse reactions, concomitant strong CYP3A4 inhibitors: see full labeling. Severe hepatic impairment: reduce frequency to once daily. Children: Not established. Warnings/Precautions: Advise patients to initiate antidiarrheal (eg, loperamide) and increase fluids at first sign of loose stools; discontinue if Grade 3/4 diarrhea occurs or hospitalization required, until resolves. Monitor CBCs and LFTs prior to initiation and every 2 weeks for the first 2 months, then monthly for the next 2 months, and as clinically indicated. Dose interruption/reduction/discontinuation or delay in starting treatment cycles if Grade 3/4 neutropenia, recurrent Grade 2 or Grade 3/4 transaminase elevation occurs. Monitor for signs/symptoms of venous thromboembolic events; treat appropriately. Severe hepatic impairment. Embryo-fetal toxicity. Females of reproductive potential should use effective contraception during therapy and for at least 3 weeks after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for at least 3 weeks after the last dose). Interactions: Avoid concomitant ketoconazole, grapefruit products. Concomitant other strong CYP3A inhibitors: reduce abemaciclib dose. Avoid concomitant strong CYP3A inducers (eg, rifampin): consider alternative agents. Pharmacological Class: Kinase inhibitor. Adverse Reactions: Diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, thrombocytopenia; venous thromboembolism, hepatotoxicity. Generic Availability: NO How Supplied: Blister pack—14