brance (palbociclib) approved by NICE via the Cancer Drugs Fund for women with previously treated HR positive, HER2 negative metastatic breast cancer


2019-11-29 16:00:45 nice


The National Institute for Health and Clinical Optimization (NICE) in the UK has approved the availability of targeted anti-cancer drugs Ibrance (Chinese name: Aibo Xin ?, generic name: palbociclib, piperbexili), combined with fluoride Vesiteron is used to treat patients with hormone receptor positive (HR +), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer who have previously received endocrine therapy. This decision means that the Ibrance joint Fulvestrant program will enter the National Service System (NHS) through the CDF and take effect immediately. It is estimated that approximately 3,200 women with HR + / HER2-breast cancer in the UK are eligible for this regimen. Results from the Phase III clinical trial PALOMA-3 show that in patients with HR + / HER2- breast cancer who have progressed during or after receiving endocrine therapy, Ibrance + Fulvestrant will progress the disease compared to placebo + Fulvestrant Delayed by 6.6 months (11.2 months vs 4.6 months; HR = 0.497 [95% CI: 0.398-0.62]). By prolonging progression-free survival (PFS), the combination of Ibrance + Fulvestrant therapy delays the need for follow-up treatments, including chemotherapy, and enables patients to live better with long-term stable disease. Ibrance is a pioneering oral targeted CDK4 / 6 inhibitor that selectively inhibits cyclin-dependent kinases 4 and 6 (CDK4 / 6), restores cell cycle control and blocks tumor cell proliferation. Cell cycle runaway is a hallmark feature of cancer. CDK4 / 6 is overactive in many cancers, leading to uncontrolled cell proliferation. CDK4 / 6 is a key regulator of the cell cycle and can trigger the transition of the cell cycle from the growth phase (G1 phase) to the DNA replication phase (S1 phase). In estrogen receptor-positive (ER +) breast cancer, CDK4 / 6 is overactive and CDK4 / 6 is a key downstream target of ER signaling. Preclinical data show that the dual inhibition of CDK4 / 6 and ER signals has a synergistic effect and can inhibit the growth of G1 phase ER + breast cancer cells. Ibrance is the first CDK4 / 6 inhibitor to be marketed globally. It was approved for the first time in February 2015. So far, it has been approved by more than 90 countries worldwide for first- and second-line treatment of HR + / HER2- breast cancer. In April 2019, Ibrance was approved by the US FDA, becoming the world's first and only CDK4 / 6 inhibitor for first-line treatment of HR + / HER2-metastatic breast cancer patients with aromatase inhibitors. In the United States, Ibrance is used to treat adult patients with HR + / HER2- advanced or metastatic breast cancer: (1) in combination with an aromatase inhibitor as an initial endocrine therapy for postmenopausal women or men; (2) in combination with fulvestr The group is used for patients who have progressed after receiving endocrine therapy. In China, Ibrance was approved in August 2018 in combination with aromatase inhibitors as an initial endocrine therapy for the treatment of women with postmenopausal women with HR + / HER2- locally advanced or metastatic breast cancer. In 2018, Ibrance had global sales of $ 4.118 billion. Previously, the pharmaceutical market research organization EvaluatePharma released a report predicting that Ibrance's global sales in 2024 will reach 9.128 billion US dollars, becoming the world's best-selling CDK4 / 6 inhibitor, with a CAGR of 14.2% over the forecast period .
英国国家卫生与临床优化研究所(NICE)已批准可通过癌症药物基金(CDF)获取靶向抗癌药Ibrance(中文商品名:爱博新?,通用名:palbociclib,哌柏西利),联合氟维司群用于治疗先前已接受过内分泌疗法的激素受体阳性(HR+)、人表皮生长因子受体2阴性(HER2-)局部晚期或转移性乳腺癌患者。 这一决定意味着,Ibrance联合氟维司群方案将通过CDF进入国家服务系统(NHS)并立即生效。据估计,英国大约有3200例HR+/HER2-乳腺癌女性患者有资格接受该方案治疗。 来自III期临床试验PALOMA-3的结果显示,在接受内分泌疗法期间或之后病情进展的HR+/HER2-乳腺癌患者中,与安慰剂+氟维司群相比,Ibrance+氟维司群将疾病进展延迟了6.6个月(11.2个月 vs 4.6个月;HR=0.497[95%CI:0.398-0.62])。通过延长无进展生存期(PFS),Ibrance+氟维司群组合疗法推迟了对后续治疗(包括化疗)的需求,使患者在疾病长期稳定的情况下生活的更好。 Ibrance是一种首创的口服靶向性CDK4/6抑制剂,能够选择性抑制细胞周期蛋白依赖性激酶4和6(CDK4/6),恢复细胞周期控制,阻断肿瘤细胞增殖。细胞周期失控是癌症的一个标志性特征,CDK4/6在许多癌症中均过度活跃,导致细胞增殖失控。CDK4/6是细胞周期的关键调节因子,能够触发细胞周期从生长期(G1期)向DNA复制期(S1期)转变。在雌激素受体阳性(ER+)乳腺癌中,CDK4/6的过度活跃非常频繁,而CDK4/6是ER信号的关键下游靶标。临床前数据表明,CDK4/6和ER信号双重抑制具有协同作用,并能够抑制G1期ER+乳腺癌细胞的生长。 Ibrance是全球上市的首个CDK4/6抑制剂,于2015年2月首次获批上市,截止目前已获全球90多个国家批准用于HR+/HER2-乳腺癌的一线、二线治疗。2019年4月,Ibrance获美国FDA批准,成为全球首个也是唯一一个联合芳香酶抑制剂一线治疗HR+/HER2-转移性乳腺癌男性患者CDK4/6抑制剂。在美国,Ibrance用于治疗HR+/HER2-晚期或转移性乳腺癌成人患者:(1)联合一种芳香酶抑制剂作为初始内分泌疗法,用于绝经后女性或男性;(2)联合氟维司群用于接受内分泌疗法后病情进展的患者。 在中国,Ibrance(爱博新)于2018年8月获批,联合芳香酶抑制剂,作为一种初始内分泌疗法,用于HR+/HER2-局部晚期或转移性乳腺癌绝经后女性患者的治疗。 在2018年,Ibrance的全球销售额高达41.18亿美元。此前,医药市场调研机构EvaluatePharma发布报告预测,Ibrance在2024年的全球销售额将达到91.28亿美元,成为全球最畅销的CDK4/6抑制剂,预测期内的年复合增长率(CAGR)高达14.2%。