Onyx is advancing a robust pipeline of innovative investigational therapies targeting several molecular pathways in cancers, with the goal of extending and enhancing the lives of patients.
The goal of the development program for sorafenib, an oral anticancer drug currently approved to treat two cancers, is to further evaluate the drug's efficacy, safety, and potential to be combined with other anti-cancer agents in the treatment of a range of cancers.
Sorafenib has been evaluated in a Phase 3 trial to determine its potential in thyroid cancer, and is currently being evaluated in late-stage studies in breast cancer and as an add-on treatment for liver and kidney cancer following surgery. Sorafenib is developed and marketed in collaboration with Bayer HealthCare Pharmaceuticals, Inc.
The goal of the development program for carfilzomib, a proteasome inhibitor currently approved in the U.S. for one type of multiple myeloma, is to further evaluate the drug’s efficacy and safety both as a single-agent and in combination with other therapies across the spectrum of multiple myeloma disease states. Multiple clinical trials evaluating carfilzomib either as a single-agent or in combination with other therapies for the treatment of patients with multiple myeloma are currently ongoing.
Palbociclib, an oral small molecule cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor identified through a research collaboration between Onyx and Pfizer, is currently in Phase 3 clinical development by Pfizer for advanced breast cancer. Palbociclib is a Pfizer compound, and if commercialized by Pfizer, Onyx would receive milestone payments and an 8% royalty on any future net sales worldwide. In April 2013, palbociclib received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with breast cancer. For more information on the clinical development of palbociclib, please visit Pfizer.com
Earlier Stage Pipeline
In addition to carfilzomib, our proteasome inhibitor program includes oprozomib, an oral proteasome inhibitor currently in Phase 1b/2 clinical testing. It also includes ONX 0914, an immunoproteasome inhibitor with preclinical activity in models of autoimmune disorders.
ONX 0801 is a folate receptor-targeted thymidylate synthase inhibitor in-licensed from BTC International. The compound is currently in Phase 1 clinical testing for the treatment of solid tumors