The US Food and Drug Administration (FDA) granted Breakthrough Therapy designation to ribociclib as an initial endocrine-based therapy for premenopausal or perimenopausal women with hormone-receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2–) advanced or metastatic breast cancer plus tamoxifen or an aromatase inhibitor.

The designation was based on results from the MONALEESA-7 phase 3 study, for which researchers randomly assigned 672 premenopausal or perimenopausal women with HR+/HER2– advanced breast cancer to receive ribociclib or placebo, plus tamoxifen or nonsteroidal aromatase inhibitor (eg, letrozole, anastrozole) and goserelin. Study patients had previously not received endocrine therapy for advanced disease.

After a median follow-up of 19 months, results demonstrated that patients in the ribociclib arm had a median progression-free survival (PFS) of 23.8 months (95% CI, 19.2 – not reached) vs 13.0 months (95% CI, 11.0-16.4) for patients who received endocrine therapy alone. Overall response rate was also significantly prolonged among women who received ribociclib.

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The most frequently reported adverse events (AEs) and grade 3 to 4 AEs for which incidence with ribociclib plus letrozole exceeded placebo plus letrozole included blood and lympathic system disorders, such as neutropenia and leukopenia; headache; back pain; nausea; fatigue; diarrhea; vomiting; and constipation.

FDA breakthrough therapy designation is granted to medications for which early analyses demonstrate improved clinical benefit for serious conditions.


Novartis Kisqali received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2– advanced breast cancer [press release]. Basel, Switzerland: Novartis; January 3, 2018. Accessed January 3, 2018.