ArQule and Daiichi Sankyo Reach Agreement with FDA

ArQule, Inc. ARQL today announced a Special Protocol Assessment agreement with the U.S. Food and Drug Administration for the design of a Phase 3 trial of ARQ 197 in patients with non-small cell lung cancer of non-squamous histology. Daiichi Sankyo Co., Ltd., the holder of the Investigational New Drug application for ARQ 197 and ArQule's partner for the development of the compound, will conduct the Phase 3 trial, which is planned for initiation later this year.