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Abemaciclib, sold under the brand name Verzenio among others, is a medication for the treatment of advanced or metastatic breast cancers. It was developed by Eli Lilly and it acts as a CDK inhibitor selective for CDK4 and CDK6.
Read the full article on WikipediaLocally advanced or metastatic breast cancer Clinical criteria: Treatment Phase: Initial treatment Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; OR Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, AND The condition must be hormone receptor positive, AND The condition must be human epidermal growth factor receptor 2 (HER2) negative, AND The condition must be inoperable, AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less, AND The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; OR The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only, AND The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy. Treatment criteria: Must be treated by a medical practitioner. Population criteria: Patient must not be premenopausal. PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
Early breast cancer Clinical criteria: The treatment must be adjuvant to surgical resection, AND Patient must have been untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy at the time non-PBS-subsidised or PBS-subsidised treatment was initiated; OR Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal, AND The condition must not have been treated with adjuvant endocrine therapy for more than 6 months prior to commencing this drug, AND The condition must be human epidermal growth factor receptor 2 (HER2) negative, AND The condition must be hormone receptor positive, AND The condition must be at high risk of recurrence at treatment initiation with this drug, with high risk being any of: (a) cancer cells in at least 4 positive axillary lymph nodes, (b) cancer cells in 1 to 3 positive axillary lymph nodes plus at least one of: (i) tumour size of at least 5 cm in size, (ii) grade 3 tumour histology (on the Nottingham grading system), AND The treatment must not be a PBS-subsidised benefit beyond whichever comes first: (i) a total of 2 years of active treatment (this includes any non-PBS-subsidised supply if applicable), (ii) disease recurrence/progression, AND The treatment must not be in combination with any of the following: (i) olaparib, (ii) pembrolizumab, (iii) ribociclib. Treatment criteria: Patient must be undergoing concurrent treatment with endocrine therapy where this drug is being prescribed as a PBS benefit, AND Must be treated by a medical practitioner; OR Must be treated by a nurse practitioner where both of the following are occurring: (i) patient care is being shared with a medical practitioner, (ii) the prescription continues existing therapy with this medicine. Retain all pathology imaging and investigative test results in the patient's medical records. PBS-subsidised treatment with CDK 4/6 inhibitors is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).
“Like the related drugs palbociclib and ribociclib, abemaciclib inhibits the enzymes cyclin-dependent kinase 4 (CDK4) and cyclin-dependent kinase 6 (CDK6). These enzymes are responsible for phosphorylating and thus deactivating the retinoblastoma protein, which plays a role in cell cycle progression from the G1 (first gap) to the S (synthesis) phase. Blocking this pathway prevents cells from progressing to the S phase, thereby inducing apoptosis (cell death). In vitro analysis using cancer cell lines, it is reported that abemaciclib induces non-apoptotic cell death characterized by formation of cytoplasmic vacuoles derived from lysosomes. This result suggests that there may be a mechanism of action other than inhibition of a cyclin-dependent kinase.”
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