publication date: Sep. 22, 2016

Regulatory Actions Novartis, MEI Pharma. Receive Breakthrough Therapy Designations

FDA granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor.

The designation is based primarily on results of the phase III MONALEESA-2 trial in postmenopausal women who had received no prior therapy for their advanced disease. The trial met its primary endpoint of progression free survival at a pre-planned interim analysis.

Results of this study will be presented at an upcoming medical congress and will form the basis of regulatory discussions in the US, Europe and other countries for use in this indication, according to the drug’s sponsor, Novartis.

LEE011 has been studied in non-clinical models and is currently being evaluated in combination with additional endocrine agents as part of the MONALEESA (Mammary ONcology Assessment of LEE011’s Efficacy and SAfety) clinical trial program. LEE011 is not approved for any indication in any market at this time. LEE011 was developed by Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals.

FDA and the Centers for Medicare and Medicaid Services accepted the FoundationOne comprehensive genomic profiling assay for parallel review. FDA also accepted Foundation Medicine’s request for review as part of its Expedited … Continue reading CCL 39-08 Novartis, MEI Pharma. Receive Breakthrough Therapy Designations

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