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FDA grants breakthrough therapy designation to Kisqali for certain premenopausal women with breast cancer
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The FDA granted breakthrough therapy designation to ribociclib in combination with tamoxifen or an aromatase inhibitor for initial endocrine-based treatment of premenopausal women with hormone receptor-positive, HER-2-negative advanced breast cancer.
Ribociclib (Kisqali, Novartis) — a selective cyclin-dependent kinase inhibitor — is currently approved in combination with letrozole for initial treatment of postmenopausal women with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer.
The FDA based the breakthrough therapy designation on results from the randomized phase 3 MONALEESA-7 trial, which included 672 premenopausal or perimenopausal women aged 25 to 58 years with hormone receptor-positive, HER-2-negative advanced breast cancer.
Researchers assigned women to oral hormonal therapy with tamoxifen or an aromatase inhibitor plus either ribociclib or placebo. All patients also received goserelin.
Investigators presented results in December at San Antonio Breast Cancer Symposium.
As HemOnc Today previously reported, results showed the addition of ribociclib to endocrine therapy prolonged median PFS (23.8 months vs. 13 months; HR = 0.55; 95% CI, 0.44-0.69).
Researchers observed similar benefit with ribociclib for patients who received tamoxifen (median PFS, 22.1 months) or an aromatase inhibitor (median PFS, 27.5 months). They also observed benefit across all patient subgroups.
“This breakthrough therapy designation reflects the significance and promise of the MONALEESA-7 data,” Samit Hirawat, MD, head of Novartis Oncology’s global drug development, said in a company-issued press release. “Younger women often have distinct treatment goals and needs, and it is important for oncologists to offer effective and well-studied treatment options for their specific disease.”
The investigators did not observe new safety signals in the trial. Similar percentages of patients assigned the ribociclib combination or endocrine therapy alone discontinued treatment due to adverse events (3.6% vs. 3%).
The most common grade 3 to grade 4 adverse events in the combination group included neutropenia (60.6% for combination therapy vs. 3.6% for endocrine therapy alone) and leukopenia (14.3% vs. 1.2%).
“We look forward to working with FDA to make this combination therapy available to premenopausal women living with hormone receptor-positive, HER-2-negative advanced breast cancer in the United States as soon as possible,” Hirawat said.