Lung cancer remains the leading cause of cancer-related deaths worldwide. In the United States, NSCLC accounts for 75–80% of all lung cancers. Although progress has been made in recent years the majority of patients with advanced stage lung cancer still die from their disease. New treatments are sorely needed. Clovis Oncology Inc. recently reported that its lung-cancer treatment received breakthrough therapy status from the U.S. Food and Drug Administration.
The company is currently developing CO-1686, a drug for the treatment of non-small cell lung cancer. CO-1686 therapy targets a specific genetic mutation, and the company noted on Monday that the breakthrough-therapy designation is intended to speed up the development of drugs for serious or life-threatening conditions. “This designation is well timed for us as well, as the increased interaction with FDA that it provides will come as we are initiating our registration studies and preparing to submit our initial new drug application by mid-2015,” said Chief Executive Patrick Mahaffy. It is expected that Clovis will present more results at the 2014 American Society of Clinical Oncology Annual Meeting later this month.