FDA Greenlights Lilly Early Breast Cancer Drug - with a Caveat

FDA批准礼来早期乳腺癌药物--附警告

2021-10-14 03:00:10 BioSpace

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Cristina Arias/Cover/Getty Images Eli Lilly announced that the U.S. Food and Drug Administration (FDA) had approved its Verzenio (abemaciclib) for a specific type of early breast cancer that is at high risk of recurrence after surgery.  The drug is limited to patients who test at least 20% for a Ki-67 score on an FDA-approved test. Ki-67 is a marker of cellular proliferation. This limitation is likely to make the rollout of the drug to be a bit tougher. The specific approval is for Verzenio in combination with endocrine therapy, such as tamoxifen or an aromatase inhibitor, for adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence and a Ki-67 score of greater than or equal to 20%. Verzenio is a CDK4/6 inhibitor. “Over time, the collective results of the Verzenio clinical development program have demonstrated a differentiated CDK4/6 inhibitor profile, and the landmark data from the monarchE trial that supported this new indication in HR+ HER2- early breast cancer represent another important step forward for people who are in need of new treatment options,” said Jacob Van Naarden, Senior Vice President, Chief Executive Officer of Loxo Oncology at Lilly and President, Lilly Oncology. “We are pleased with this initial approval in the adjuvant setting and as these data continue to mature, we look forward to further opportunities to work with health authorities to expand the use of Verzenio in this setting.” This is the first CDK4/6 inhibitor approved for this setting. In 2020, Pfizer's Phase III trial of its own CDK4/6 inhibitor, Ibrance, failed to hit its primary endpoint in this setting. Novartis is evaluating its Kisqali for this indication but won’t have data available until late 2022. The Lilly approval was based on the Phase III monarchE study. Patients were randomized to receive two years of Verzenio twice a day plus the physician’s choice of standard endocrine therapy or standard endocrine therapy alone. They continued to receive adjuvant endocrine therapy for up to five to 10 years. The primary endpoint was invasive disease-free survival (IDFS), which was met at a pre-specific interim analysis. It demonstrated statistically significant improvement in IDFS for patients receiving Verzenio plus ET compared to the patients receiving ET alone. A pre-specified analysis was also run of IDFS in patients with high-risk clinical and pathological factors and a Ki-67 score of 20% or greater. This included patients with five or higher positive axillary lymph nodes (ALN) or 1-3 positive ALN with either Grade 3 disease and/or tumor size of 5 cm or greater and whose tumors had a Ki-67 score of 20% or greater. This group also had a statistically significant improvement in IDFS. “Women and men living with high-risk HR+ HER2- early breast cancer want to do all they can to reduce the risk of the disease coming back, with the hope of living free of cancer,” said Jean Sachs, Chief Executive Officer, Living Beyond Breast Cancer. “This approval of Verzenio provides a new treatment option to help them do just that. This approval brings new optimism to the breast cancer community.” The company expects to present data supporting the approval at the European Society for Medical Oncology (ESMO) Virtual Plenary on October 14.
克里斯蒂娜·阿里亚斯/封面/盖蒂图像公司 礼来公司宣布,美国食品药品监督管理局(FDA)已批准其Verzenio(abemaciclib)用于一种特定类型的早期乳腺癌,这种乳腺癌术后复发风险很高。 这种药物仅限于在FDA批准的测试中测试至少20%的Ki-67分数的患者。Ki-67是细胞增殖的标志物。这种限制可能会使这种药物的推出变得更加困难。 具体批准是Verzenio与内分泌治疗(如他莫昔芬或芳香化酶抑制剂)相结合,用于激素受体阳性(HR+)、人表皮生长因子受体2阴性(HER2-)、结节阳性、复发风险高且Ki-67评分大于或等于20%的成人早期乳腺癌(EBC)的辅助治疗。Verzenio是CDK4/6抑制剂。 礼来公司洛索肿瘤学高级副总裁、首席执行官兼礼来肿瘤学总裁雅各布·范·纳登(Jacob Van Naarden)表示:“随着时间的推移,Verzenio临床开发项目的集体结果已经证明了一种分化的CDK4/6抑制剂图谱,来自君主试验的里程碑式数据支持了HR+HER2早期乳腺癌的这一新适应症,这对需要新治疗选择的人来说又向前迈出了重要的一步。”“我们对佐剂环境中的这一初步批准感到高兴,随着这些数据的继续成熟,我们期待着与卫生当局合作的进一步机会,以扩大Verzenio在这一环境中的使用。” 这是第一个批准用于此设置的CDK4/6抑制剂。2020年,辉瑞自己的CDK4/6抑制剂Ibrance的第三期试验在这种情况下未能达到其主要终点。诺华正在评估其Kisqali是否有这一迹象,但要到2022年底才会有数据。 礼来的批准是基于第三阶段君主研究。患者随机接受为期两年的Verzenio治疗,每天两次,加上医生选择的标准内分泌治疗或单独标准内分泌治疗。他们继续接受辅助内分泌治疗长达5至10年。主要终点是侵袭性无病生存率(IDFS),在特异性前期中期分析中达到。结果显示,与单纯接受ET相比,接受Verzenio加ET的患者在IDFS方面有统计学意义的改善。 在具有高危临床和病理因素且Ki-67评分为20%或更高的患者中,也进行了预先指定的IDFS分析。这包括5个或更高的阳性腋窝淋巴结(ALN)或1-3个阳性ALN,3级疾病和/或肿瘤大小为5厘米或更大,且肿瘤Ki-67评分为20%或更大的患者。这一组在IDFS方面也有统计学意义上的改善。 《生活在乳腺癌之外》首席执行官让·萨克斯(Jean Sachs)表示:“患有高危HR+HER2早期乳腺癌的女性和男性希望尽一切努力降低疾病复发的风险,希望生活在没有癌症的环境中。”“Verzenio的批准提供了一种新的治疗选择来帮助他们做到这一点。这一批准给乳腺癌界带来了新的乐观情绪。“ 该公司预计将于10月14日在欧洲医学肿瘤学会(ESMO)虚拟全体会议上提交支持批准的数据。

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