FDA Expands Indication for Ribociclib in Advanced Breast Cancer
Posted: Tuesday, July 24, 2018
The U.S. Food and Drug Administration (FDA) recently expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for premenopausal/perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy. The FDA also approved ribociclib in combination with fulvestrant for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial endocrine-based therapy or after disease progression on endocrine therapy.
Ribociclib was previously approved for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine therapy.
The efficacy of ribociclib in combination with an aromatase inhibitor for premenopausal/perimenopausal women was based on MONALEESA-7, a randomized, double-blind, placebo-controlled trial. Premenopausal/perimenopausal women were randomized to receive ribociclib plus either a nonsteroidal aromatase inhibitor or tamoxifen and goserelin versus placebo plus either a nonsteroidal aromatase inhibitor or tamoxifen and goserelin.
The results from the prespecified nonsteroidal aromatase inhibitor–only subgroup of 495 premenopausal/perimenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who received no prior endocrine therapy for advanced disease showed an estimated median progression-free survival of 27.5 months for patients on the ribociclib arm compared with 13.8 months for those on the placebo arm. Ribociclib is not indicated for concomitant use with tamoxifen.
The most common adverse reactions in at least 20% of patients were neutropenia, nausea, infections, fatigue, diarrhea, leukopenia, vomiting, alopecia, headache, constipation, rash, and cough.
