Kisqali Receives New Indications
July 18, 2018 – The U.S. FDA has approved a new indication for Novartis’s Kisqali® (ribociclib) to be used in combination with an aromatase inhibitor as an initial endocrine-based therapy for women who have advanced or metastatic breast cancer. Eligible patients must be pre/perimenopausal or postmenopausal and hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative.
In addition, the FDA has approved Kisqali for use in combination with fulvestrant as an initial endocrine-based therapy or following disease progression on endocrine therapy for postmenopausal women who have HR-positive, HER2-negative advanced or metastatic breast cancer.
The new indications are the first approvals granted to an oncology product through two new pilot programs – Real-Time Oncology Review, and Assessment Aid – designed to improve the efficiency of cancer drug reviews. According to the FDA, the process allows real-time review and analysis of clinical trial data as soon as it becomes available, which can reduce the wait for an FDA decision once the organization receives a formal application for drug approval. The pilot programs are currently only available for supplemental applications for already-approved cancer drugs.
In clinical trials, Kisqali used with an aromatase inhibitor (AI) significantly improved the median progression-free survival time (27.5 months) compared to placebo plus an AI (13.8 months). When used with fulvestrant, Kisqali also improved median progression-free survival time (20.5 months) compared to placebo plus fulvestrant (12.8 months).
Kisqali first received FDA approval in 2017 for use in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
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