ArQule and Daiichi Sankyo Reach Agreement with FDA
ArQule, Inc. (Nasdaq: 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.
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