Express CDK4/6 inhibitors received FDA approval for the first time to treat early-stage breast cancer

▎The content team editor of WuXi AppTec today, Eli Lilly and Company announced that the US FDA has approved the expanded indications of the CDK4/6 inhibitor Verzenio (abemaciclib), combined with endocrine therapy (tamoxifen or aromatase inhibition).
Drugs), adjuvant therapy for early breast cancer patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), lymph node positive, and high risk of recurrence
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These patients were determined to have a Ki-67 score of ≥20% by a test approved by the US FDA
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Ki-67 is a marker of cell proliferation
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The press release states that Verzenio is the first CDK4/6 inhibitor approved for use in this patient population
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Breast cancer has surpassed lung cancer as the most common cancer in the world, with approximately 2.
3 million newly diagnosed patients in 2020
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It is estimated that about 90% of breast cancer patients are in the early stage of cancer when they are diagnosed.
Although most early-stage HR+, HER2- breast cancer patients have a positive prognosis, about 20% of patients will relapse and may develop metastatic disease
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Patients with cancer cells and other high-risk characteristics found in the lymph nodes are more likely to relapse, and they need innovative therapies to prevent the recurrence of the disease
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This approval is based on an open-label, phase 3 clinical trial of patient subgroup analysis results
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This patient subgroup includes more than 2,000 patients with a variety of high-risk recurrence characteristics, including Ki-67 score ≥20%, cancer cells found in more than four axillary lymph nodes, or cancer cells found in 1-3 axillary lymph nodes and The size of the tumor exceeds 5 cm and so on
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The analysis of this patient subgroup showed that Verzenio combined with endocrine therapy, compared with endocrine therapy alone, reduced the risk of recurrence in patients by approximately 36% (HR=0.
643, 95% CI: 0.
475, 0.
872, p=0.
0042)
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In the Verzenio combination therapy group, there were 104 recurrences of invasive disease, and the value in the endocrine therapy single-agent group was 158
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The overall survival data is not yet mature
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Verzenio (abemaciclib) is a CDK4/6 inhibitor
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In HR+ breast cancer cell lines, cyclin D1 and CDK4/6 promote cell cycle progression and cell proliferation
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Verzenio can block the progression of the cell cycle, leading to cell senescence and apoptosis
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It has been approved by the FDA as a first-line therapy for HR+, HER2- advanced breast cancer patients
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Mr.
Jacob Van Naarden, President of Eli Lilly Oncology and CEO of Loxo Oncology, said: "We are very pleased that Verzenio has been approved as an adjuvant therapy
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As the data continues to mature, we look forward to cooperating with regulatory agencies in the future to expand the applicability of Verzenio as an adjuvant therapy.
Range
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"Reference: [1] FDA Approves Verzenio® (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer.
Retrieved October 13, 2021, from https://investor.
lilly .
com/news-releases/news-release-details/fda-approves-verzenior-abemaciclib-first-and-only-cdk46 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.

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in the
article .
This article is not a treatment plan recommendation
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