pharmaphorum September 18, 2024
Phil Taylor

Novartis’ CDK4/6 inhibitor Kisqali has claimed a broad FDA approval in early breast cancer that could give it an edge over class rival Verzenio from Eli Lilly.

The US regulator has cleared Kisqali (ribociclib) to reduce the risk of recurrence in patients with HR+/HER2- early breast cancer, based on the results of the NATALEE trial. In the study, Kisqali given alongside endocrine therapy as adjuvant therapy for stage 2 or 3 patients reduced their risk of recurrence by 25% compared to those on the endocrine therapy alone after three years.

Verzenio was approved for a similar adjuvant indication last year, having been used for a couple of years only in patients who tested positive for a specific biomarker. However, its...

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