Clinical Pipeline

DiscoveryPhase 1Phase 2Phase 3Marketed

Kisqali® (ribociclib)

CDK4/6 inhibitor (Oncology)

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Partner: novartis-med

Mechanism of Action:  Cyclin dependent kinase (CDK) 4/6 inhibition

Indication: Oncology

Discovery: Kisqali® (ribociclib, formerly known as LEE011) was developed by Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex announced in December 2005.

Learn about the Kisqali® drug discovery program:

How this therapy can help

Kisqali® is a selective CDK inhibitor, a new class of drugs that help slow the progression of cancer by inhibiting two proteins called CDK 4 and 6 (CDK4/6). These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly. Kisqali® is the only CDK4/6 inhibitor, in combination with endocrine therapy, to show superior overall survival compared to endocrine therapy alone in advanced breast cancer.

Marketed product

Kisqali® received US marketing approval by the FDA in March 2017 and by the EMA in August 2017 as a first-line drug treatment for postmenopausal women with HR+/HER2- advanced breast cancer in combination with an aromatase inhibitor. For full prescribing and safety information please see here.

Kisqali® received US marketing approval in July 2018 and European marketing approval in December 2018 as a first-line drug treatment in combination with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women with HR+/HER2- advanced or metastatic breast cancer and also for use in combination with fulvestrant as both first-line and second-line therapy in postmenopausal women.

Kisqali® has now been approved for use in more than 75 countries including the US and EU member states.

Clinical studies

Kisqali® continues to be evaluated by Novartis in combination with a number of other endocrine agents in their on-going clinical trials program.