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Name
Abemaciclib
Alternate Names
LY2835219
Verzenio
Abbreviations
None
Category
Chemotherapy
Subcategory
Cyclin-dependent kinase inhibitor
NSC Number
None
Primary Site
Breast
Histology
None
Remarks
March 10, 2023 FDA has approved an expanded indication for Verzenio (abemaciclib), in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence.
Prior to 9/28/2017: The FDA has granted the CDK4/6 inhibitor abemaciclib (LY2835219) a breakthrough therapy designation as monotherapy for heavily pretreated patients with refractory hormone-receptor (HR)-positive advanced breast cancer, based on data from a phase I study.
Coding instructions: The drug is currently in clinical trials and has not yet received FDA approval. Code as Other Treatment and assign code 2.
September 28, 2017: FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones.
March 6, 2018 FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
October 12, 2021 The FDA abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.
Prior to 9/28/2017: The FDA has granted the CDK4/6 inhibitor abemaciclib (LY2835219) a breakthrough therapy designation as monotherapy for heavily pretreated patients with refractory hormone-receptor (HR)-positive advanced breast cancer, based on data from a phase I study.
Coding instructions: The drug is currently in clinical trials and has not yet received FDA approval. Code as Other Treatment and assign code 2.
September 28, 2017: FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones.
March 6, 2018 FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.
October 12, 2021 The FDA abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test. This is the first CDK 4/6 inhibitor approved for adjuvant treatment of breast cancer.
Coding
This drug should be coded
