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FDA grants ribociclib breakthrough therapy designation for advanced breast cancer
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The FDA granted ribociclib breakthrough therapy designation for use in combination with letrozole for first-line treatment of patients with advanced or metastatic hormone receptor–positive, HER-2–negative breast cancer.
Ribociclib (LEE011, Novartis) inhibits cyclin dependent kinase 4 and 6 proteins which, when over activated, can enable cancer cells to grow and divide too quickly.
The decision was based, in part, on results of the phase 3 MONALEESA-2 trial, which evaluated ribociclib in combination with letrozole in postmenopausal women who had not yet been treated for their advanced disease.
Results of a preplanned interim analysis showed the trial met its primary endpoint of a clinically meaningful improvement in PFS. Data from the trial — scheduled for presentation at an upcoming medical congress — will form the basis for regulatory discussions, according to a press release from the drug’s manufacturer.
“Despite advancements in treatment, an estimated 40,000 individuals in the United States die each year from advanced breast cancer,” Alessandro Riva, MD, global head of oncology development and medical affairs at Novartis Oncology, said in the release. “This designation shows the potential of LEE011, and we look forward to close collaboration with the FDA and the advanced breast cancer community to provide a new treatment option for women living with hormone receptor–positive/HER-2–negative advanced breast cancer as quickly as possible.”
In the MONALEESA-3 trial, the addition of ribociclib to fulvestrant (Faslodex, AstraZeneca) is under investigation in men and postmenopausal women with hormone receptor–positive, HER-2–negative advanced breast cancer who have received no more than one prior endocrine therapy. Ribociclib also is being evaluated in combination with endocrine therapy and goserelin (Zoladex, AstraZeneca) in the MONALEESA-7 trial for premenopausal women with advanced breast cancer who have not previously received endocrine therapy.