Threshold Pharmaceuticals Inc. (THLD) announced U.S. Food and Drug Administration has reached agreement with the U.S. affiliate of Merck KGaA (MRK), Darmstadt, Germany, Threshold's partner for the development and commercialization of TH-302, covering a Special Protocol Assessment for a Phase 3 randomized trial of TH-302 in patients with metastatic or locally advanced unresectable pancreatic cancer. The trial is designed to evaluate the efficacy and safety of TH-302 in combination with gemcitabine compared with gemcitabine therapy alone. Pursuant to Threshold's license and co-development agreement with Merck, Merck will be responsible for conducting the Phase 3 study under the SPA.
A Special Protocol Assessment, or SPA, is a written agreement with the FDA that documents FDA's agreement that the design and planned analysis of a study can adequately address objectives in support of a regulatory submission. However, FDA's determinations for marketing application approval are made after a complete review of a marketing application and are based on the entire data in the application.
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