Adjuvant abemaciclib gets go-ahead from FDA for early breast cancer
medwireNews: Patients with hormone receptor (HR)-positive, HER2-negative early breast cancer can now be treated with adjuvant abemaciclib in combination with endocrine therapy, following US FDA approval.
This is the first CDK4/6 inhibitor approved by the regulatory agency in the adjuvant breast cancer setting, and is specifically indicated for individuals with a high recurrence risk and a Ki-67 score of 20% or higher.
The FDA also approved a companion diagnostic assay – namely Ki-67 IHC MIB-1 pharmDx (Agilent, Inc, Santa Clara, California, USA) – to identify patients who can receive abemaciclib.
The decision is based on results from the phase 3 monarchE trial that showed a significant invasive disease-free survival benefit with the use of abemaciclib alongside endocrine therapy in this patient population.
As per the prescribing information, abemaciclib should be given at a starting dose of 150 mg twice daily in combination with tamoxifen or an aromatase inhibitor for up to 2 years.
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