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01-03-2018 | FDA | News


First-line abemaciclib plus an aromatase inhibitor receives FDA approval

medwireNews: The CDK4/6 inhibitor abemaciclib has received US FDA approval for the first-line treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer.

Abemaciclib 150 mg twice daily may now be given alongside an aromatase inhibitor as the initial endocrine therapy for this patient population. The decision follows data from the MONARCH 3 clinical trial, first reported at the ESMO 2017 Congress.

The drug was previously accepted by the FDA for use in this patient population as a second-line therapy after progression during endocrine therapy.

Adverse events associated with abemaciclib include diarrhea, neutropenia, fatigue, infection, nausea, abdominal pain, and anemia.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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