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FDA Grants Breakthrough Therapy Designation to Ribociclib in Combination Therapy for Advanced Breast Cancer

By: Sarah Jackson
Posted: Thursday, January 4, 2018

On January 3, 2018, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to ribociclib (Kisqali) for initial endocrine-based treatment of pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.

This Breakthrough Therapy designation is based on the results of the phase III, randomized, double-blind, placebo-controlled MONALEESA-7 trial, which investigated the efficacy and safety of ribociclib in combination with tamoxifen or a nonsteroidal aromatase inhibitor plus goserelin versus tamoxifen or an aromatase inhibitor plus goserelin in women with hormone receptor–positive, HER2-negative advanced breast cancer who had not previously received endocrine therapy for advanced disease.

Results of the trial of nearly 700 women demonstrated ribociclib combination therapy prolonged progression-free survival compared with endocrine therapy alone (23.8 months vs. 13.0 months). The treatment benefit with the ribociclib combination therapy appeared to be consistent compared with the overall population, regardless of treatment with tamoxifen or aromatase inhibitor endocrine partners, and across predefined patient subgroups.

In subgroup analyses of median progression-free survival by endocrine partner, ribociclib in combination with tamoxifen and goserelin had a longer median progression-free survival than did tamoxifen and goserelin alone (22.1 months vs. 11.0 months). Ribociclib in combination with an aromatase inhibitor and goserelin also had a longer progression-free survival than did an aromatase inhibitor and goserelin alone (27.5 months vs. 13.8 months).

No new safety signals were observed in the MONALEESA-7 trial. The combination treatment with ribociclib was well tolerated, with the most common adverse events being neutropenia and leukopenia.