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South Delhi Pharma, New Delhi, India

KISQALI (ribociclib) tablets. FDA-Approved. To treat breast cancer

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KISQALI (ribociclib) tablets is a prescription medicine. KISQALI (ribociclib) tablets is used to treat postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
INDICATIONS AND USAGE
KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
DOSAGE FORMS & STRENGTHS: Tablets: 200 mg
Manufactured By: Novartis Pharmaceuticals Corporation
Prescribing Information URL: Click Here

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Description

Ribociclib, sold under the brand name Kisqali, is an inhibitor of cyclin D1/CDK4 and CDK6, and is used for the treatment of certain kinds of breast cancer. It is also being studied as a treatment for other drug-resistant cancers. It was developed by Novartis and Astex Pharmaceuticals.

Ribociclib was approved by the U.S. Food and Drug Administration (FDA) in March 2017, and the European Medicines Agency (EMA) in August 2017, for use in combination with an aromatase inhibitor (such as letrozole) to treat HR-positive, HER2-negative advanced or metastatic breast cancers.

In the clinical trial relevant for the drug’s approval, ribociclib significantly improved progression-free survival (PFS), that is, the time span the cancer did not get worse. For patients receiving placebo plus letrozole, PFS was 16 months on average, while under ribociclib plus letrozole, PFS was 25 months as of the January 2017 analysis. The study is scheduled to run until September 2020.

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