The FDA approved ribocilib (Kisqali; Novartis) with an aromatase inhibitor (AI) for breast cancer patients with HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. The agency also approved Novartis’s Kisqali Femara Co-Pack, which includes both ribociclib and the company’s AI, letrozole (Femara), for the same indication. In a phase III, open-label trial, invasive disease-free survival at 36 months was seen in 90.7 % of patients receiving ribociclib with a nonsteroidal AI, compared with 87.6% receiving only the nonsteroidal AI.
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