BASEL (dpa-AFX) - Novartis (NVS) said that the European Commission approved Kisqali or ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive,human epidermal growth factor receptor-2 negative or HR+/HER2- locally advanced or metastatic breast cancer as initial endocrine-based therapy.
Kisqali is the first CDK4/6 inhibitor approved in Europe based on a first-line Phase III trial that met its primary endpoint of progression-free survival or PFS at interim analysis.
EU approval follows a positive opinion granted in June by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which was based on superior efficacy and demonstrated safety of Kisqali plus letrozole versus letrozole alone in the pivotal Phase III MONALEESA-2 trial.
The company noted that Kisqali can be taken orally once-daily with or without food at a suggested starting dose of 600 mg (three 200 mg tablets) for three weeks, followed by one week off treatment. Kisqali is taken in combination with continuous use of any aromatase inhibitor.
In March 2017, the US Food and Drug Administration approved Kisqali, in combination with any aromatase inhibitor, as a treatment for metastatic breast cancer. Ribociclib in combination with letrozole was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a category 1 option for HR+/HER2- postmenopausal metastatic breast cancer patients.
Separately, Novartis said today that Bertrand Bodson, Chief Digital and Marketing Officer for Sainsbury's Argos, has been appointed to the new role of Chief Digital Officer, reporting to Joseph Jimenez, CEO of Novartis.
He will join Novartis on January 1, 2018, and will be responsible for creating and executing a company-wide digital strategy in close collaboration with the Executive Committee of Novartis, working with leadership teams across the business and external partners.
Copyright RTT News/dpa-AFX