Abemaciclib receives FDA approval
medwireNews: The US FDA has granted approval for the use of abemaciclib against HR-positive, HER2-negative advanced or metastatic breast cancer in patients who have progressed during endocrine therapy.
Based on results from the MONARCH II and MONARCH I trials, the CDK4/6 inhibitor may be given alongside the selective estrogen receptor degrader fulvestrant or used alone by patients who have previously developed metastases while using endocrine therapy plus chemotherapy.
The decision follows earlier FDA approvals of the CDK inhibitors palbociclib and ribociclib for key groups of breast cancer patients.
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