ArQule and Daiichi Sankyo have signed a special protocol assessment (SPA) agreement with the FDA for Phase 3 trial of Tivantinib in hepatocellular carcinoma (HCC).
The SPA process enables FDA to offer official evaluation and written guidance related to the design of projected procedures that are anticipated to form the origin for a new drug application. Final marketing approval is dependent on the trial's outcome.
The randomized, double-blinded study, expected to enroll 300 patients, will evaluate tivantinib as single agent therapy in patients already treated with MET diagnostic-high inoperable HCC.
The overall survival will be the primary endpoint while the secondary endpoint includes progression free survival in the same population.
ArQule and Daiichi Sankyo entered into a licensing deal for the co-development and co-commercialization of tivantinib in the US, Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, in December 2008.
ArQule chief executive officer Paolo Pucci said, "We are mindful of the high unmet need among patients suffering from this disease, and we are proceeding with our partner, Daiichi Sankyo, toward the timely initiation of this trial."
