Ribociclib indication expanded to pre-, perimenopausal patients
medwireNews: Ribociclib may now be used alongside an aromatase inhibitor as a front-line endocrine therapy approach for pre- and perimenopausal US women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, as well as their postmenopausal counterparts.
The US FDA has also approved the use of the kinase inhibitor in combination with the estrogen receptor antagonist fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic disease as both an initial endocrine therapy and as a second-line treatment after progression on endocrine therapy.
The announcement follows findings from the MONALEESA-7 study of pre- and perimenopausal women showing that improved progression-free survival with the combination versus placebo plus an aromatase inhibitor.
The recommended starting dose is 600 mg/day and common adverse reactions include neutropenia, infection, gastrointestinal side effects, and alopecia.
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