The Food and Drug Administration (FDA) has approved Kisqali (ribociclib; Novartis) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Previously, this CDK4/6 inhibitor was approved for use with an AI to treat HR-positive, HER2-negative breast cancer in postmenopausal women with advanced or metastatic breast cancer.

In addition, Kisqali has also been approved in combination with fulvestrant to treat postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy or following disease progression on endocrine therapy.

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The approval for Kisqali + an AI in pre/perimenopausal women was based on a double-blind, placebo-controlled study (MONALEESA-7) involving 495 patients who received Kisqali + a nonsteroidal aromatase inhibitor (NSAI) or tamoxifen or placebo + NSAI or tamoxifen; all patients received ovarian suppression with goserelin. The primary endpoint of the study was progression-free survival (PFS). Compared with placebo, treatment with Kisqali was associated with longer PFS (median PFS: 27.5 months vs 13.8 months; hazard ratio [HR] 0.569; 95% CI, 0.436-0.743).

The combination of Kisqali + fulvestrant was evaluated in a double-blind, placebo-controlled trial (MONALEESA-3) involving 726 postmenopausal women that also measured PFS as the primary endpoint. Compared with the placebo + fulvestrant arm, patients receiving Kisqali + fulvestrant had longer PFS (median PFS: 20.5 months vs 12.8 months; HR 0.593; 95% CI 0.480-0.732; <.0001).

In a press statement, the FDA noted that the Kisqali approvals were the first to be granted as part of 2 new pilot programs (Real-Time Oncology Review, Assessment Aid) created to improve the development and review of cancer drugs. “With today’s approval, the FDA used these new approaches to allow the review team to start analyzing data before the actual submission of the application and help guide the sponsor’s analysis of the top-line data to tease out the most relevant information,” said FDA Commissioner Scott Gottlieb, MD, “This enabled our approval less than 1 month after the June 28 submission date and several months ahead of the goal date.”

Kisqali is supplied as a 200mg tablet in 14- and 21-count blister packs.

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