FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer

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The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational drug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors.

The new agent currently is being evaluated in pancreatic cancer in the phase III MAESTRO study, which randomly assigned patients to either gemcitabine plus placebo or gemcitabine plus evofosfamide. The primary efficacy endpoint is overall survival, and secondary endpoints include efficacy measured by progression-free survival, overall response rate and disease control rate.

It is anticipated that the number of protocol-specified events for the trial may be reached in the second half of 2015, with primary efficacy analyses to be available shortly thereafter.

The compound is being developed by Merck KGaA, Darmstadt, Germany, in collaboration with Threshold Pharmaceuticals, Inc. ■




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