Astex Achieves Milestone on US FDA Filing of New Drug Application (NDA) for LEE011 (ribociclib) plus letrozole as a first-line treatment for HR+/HER2- Advanced Breast Cancer
- LEE011 (ribociclib) was developed by the Novartis Institutes for BioMedical Research under a research collaboration with Astex Pharmaceuticals
- LEE011 (ribociclib) plus letrozole significantly extended progression-free survival across all patient subgroups in the pivotal Phase 3 MONALEESA-2 clinical study compared to letrozole alone
- Separately, Novartis announced today that the US Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for filing and granted Priority Review for LEE011 (ribociclib)
- A Novartis marketing authorization application for LEE011 (ribociclib) plus letrozole has also been accepted for review by the European Medicines Agency (EMA)
Cambridge, UK, 1st November 2016. Astex Pharmaceuticals, a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it has received a milestone payment from Novartis in relation to the US FDA NDA filing by Novartis for LEE011 (ribociclib) plus letrozole as a first-line treatment for HR+/HER2- advanced breast cancer. Novartis also announced that it had received FDA Priority Review for the NDA application of LEE011 as first-line treatment of postmenopausal women with hormonereceptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole.
LEE011 (ribociclib) was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex. Under the collaboration, which commenced in 2005, NIBR scientists worked with Astex on a programme of early drug discovery research resulting in the discovery of LEE011. Novartis then led LEE011 into preclinical and later clinical development. Under terms of the agreement, Astex is eligible to receive further milestone payments in respect of additional regulatory filing and approvals in Europe and Japan, as well as royalty payment on annual sales of ribociclib should the drug be approved. Harren Jhoti, President and CEO of Astex, said, “We are absolutely delighted that Novartis has reached such a significant stage in the development of LEE011. If the product is approved, it will provide an important treatment option for many patients with advanced disease. We congratulate Novartis for an excellent job in developing LEE011 and on the achievement of US FDA Priority Review of the NDA filing.”
About LEE011 (ribociclib)
LEE011 (ribociclib) is 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. Targeting CDK4/6 with enhanced precision may play a role in ensuring cancer cells do not grow uncontrollably.
About Astex Pharmaceuticals
Astex is a leader in innovative drug discovery and development, committed to the fight against cancer and diseases of the central nervous system. Astex is developing a proprietary pipeline of novel therapies and has a number of partnered products being developed under collaborations with leading pharmaceutical companies. In October 2013 Astex became a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka – people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.
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