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Ribociclib (LEE011) Receives Regulatory Approval in U.S. 1xbet 한국/HER2- Advanced Breast Cancer with an aromatase inhibitor
- Collaborative research between 1xbet 한국's U.K. subsidiary Astex Pharmaceuticals and Novartis, which developed ribociclib and will market it
1xbet 한국., Ltd ("Otsuka") is pleased to announce that the U.S. FDA has granted regulatory approval to Novartis for ribociclib (compound number: LEE011), on which Otsuka's Cambridge-U.K. based subsidiary Astex and Novartis Institutes for BioMedical Research (NIBR) scientists jointly developed and optimised the chemical structure of ribociclib, which was then progressed through clinical trials by Novartis. Manufacturing and marketing approval was granted to Novartis for use of the drug as a first-line treatment in combination with an aromatase inhibitor for patients with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Novartis, which developed ribociclib, will market it 1xbet 한국 the U.S. as Kisqali®.
(Novartis announced the contents of this news release on March 13, 2017.)
Astex will receive from Novartis a regulatory approval milestone payment and future royalty payments based on product sales 1xbet 한국 accordance with their agreement made 1xbet 한국 2005.
Ribociclib is a cyclin-dependent kinase inhibitor developed by Novartis Institutes 1xbet 한국 Biomedical Research in a research collaboration with Astex. This drug helps slow tumor proliferation by inhibiting two proteins (CDK4 & CDK6) which, when over-activated, can enable cancer cells to grow and divide quickly. Novartis received the regulatory approval under the US FDA Breakthrough Therapy designation and Priority Review programs.
1xbet 한국 a cl1xbet 한국ical trial, a group treated with letrozole alone, a standard therapeutic treatment, was compared to a group treated with a comb1xbet 한국ation of ribociclib and letrozole. The primary endpo1xbet 한국t of progression-free survival (the period dur1xbet 한국g which cancer does not progress and is 1xbet 한국 a stable state) was extended significantly 1xbet 한국 the group treated with the comb1xbet 한국ation of ribociclib and letrozole.