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01-03-2022 | Oncology | News | Article

approvalsWatch

EMA recommends extension of abemaciclib indication

Author: Shreeya Nanda

medwireNews: The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended adopting a new indication for abemaciclib as adjuvant therapy for early breast cancer patients at high risk for recurrence.

The CDK4/6 inhibitor is indicated for individuals with hormone receptor-positive, HER2-negative, node-positive disease, and should be given in combination with endocrine therapy.

The CHMP decision also states that pre- or perimenopausal women receiving aromatase inhibitor endocrine therapy should additionally receive concurrent treatment with a luteinizing hormone-releasing hormone agonist.

This adjuvant indication was previously accepted by the US FDA in October 2021 on the basis of the phase 3 monarchE trial results.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2022 Springer Healthcare Ltd, part of the Springer Nature Group

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