MONALEESA-2 is a pivotal Phase III trial of LEE011 (ribociclib), a cyclin dependent kinase inhibitor (CDK4/6), in combination with letrozole, compared to letrozole alone in postmenopausal women ...

EAST HANOVER, N.J., March 13, 2017 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved Kisqali ® (ribociclib, formerly known as LEE011) in combination with an aromatase ...

Novartis also announced that it had received FDA Priority Review for the NDA application of LEE011 as first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal ...

LEE011, a small-molecule inhibitor of cyclin-dependent kinases (CDK) 4/6 being developed by Novartis Oncology, showed promising results in drug-resistant melanoma and drug-resistant breast cancer ...

The US Food and Drug Administration granted the Swiss pharma’s LEE011 (ribociclib) a priority review for treatment of HR+/HER2- advanced breast cancer, meaning a decision is due within six ...

Priority Review based on Phase III MONALEESA-2 trial, which showed LEE011 plus letrozole, as initial treatment for advanced breast cancer, significantly extended progression-free survival compared ...

Ribociclib, or LEE011, was also accepted by the European Medicines Agency (EMA) for review in use with letrozole in the same patient population, the company said in a statement on Tuesday.

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Says lee011 (ribociclib) stopped due to positive efficacy results at interim analysis in hr+/her2- advanced breast cancer Source text for Eikon: Further company coverage: Sign up here. European ...

Independent Data Monitoring Committee recommends stopping the trial early as it met the primary endpoint, significantly extending progression-free survival (PFS) compared to letrozole alone, at ...

The US Food and Drug Administration granted the Swiss pharma’s LEE011 (ribociclib) a priority review for treatment of HR+/HER2- advanced breast cancer, meaning a decision is due within six ...