Clovis Oncology Announces FDA Acceptance of Investigational New Drug Application for Oral EGFR Mutant-Selective Inhibitor CO-1686
Clovis Oncology, Inc. (Nasdaq: CLVS) announced today that the U.S. Food and Drug Administration has accepted the Company's investigational new drug application to begin clinical investigation of CO-1686, a novel, oral, targeted covalent inhibitor of epidermal growth factor receptor mutations in non-small cell lung cancer.
Initial Phase I/II studies are expected to commence in the U.S. and Europe during the second quarter of 2012 and in Asia during the third quarter of 2012. Following the establishment of the appropriate dose, Clovis intends to study CO-1686 in an expansion cohort of NSCLC patients who have failed either Tarceva® or Iressa® and have developed a secondary mutation, T790M, which is the dominant resistance mechanism to Tarceva and Iressa. Clovis is developing a companion diagnostic in collaboration with its partner Roche Molecular Systems, Inc. to identify patients with the T790M mutation.
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