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02-10-2017 | FDA | Article | News

approvalsWatch

Abemaciclib receives FDA approval

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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.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

See also:

·         First-line abemaciclib supported for HR+HER2– advanced breast cancer

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