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15-10-2021 | Oncology | News | Article

approvalsWatch

Adjuvant abemaciclib gets go-ahead from FDA for early breast cancer

Author:
Hannah Kitt

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.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group

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