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# FDA Priority Review for Novartis Breast Cancer Drug
- URL: https://www.fdaweb.com/fda-priority-review-for-novartis-breast-cancer-drug/
- Published: 2016-11-01T12:00:00.000Z
- Updated: 2026-09-14T21:44:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137232

FDA has accepted for priority review a Novartis NDA for LEE011 (ribociclib) as a first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. The submission is based in data from the Phase 3 MONALEESA-2 trial, which showed that LEE011 plus letrozole reduced the risk of progression or death by 44% over letrozole alone and significantly extending progression-free survival across all patient subgroups, according to the company.

  
Ribociclib is considered a selective cyclin dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin dependent kinase 4 and 6 (CDK4/6). “These proteins, when over-activated in a cell, can enable cancer cells to grow and divide too quickly,” Novartis says. “Targeting CDK4/6 with enhanced precision may play a role in ensuring cancer cells do not grow uncontrollably.”