A Phase 3 trial for the drug, TH-302, is currently ongoing.
The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. An important feature of Fast Track is that the FDA may consider a "rolling review" of completed sections of the New Drug Application (NDA) before the complete application is submitted.
Threshold Pharmaceuticals, Inc. (NASDAQ: THLD) today announced that the FDA granted Fast Track designation for TH-302, an investigational anticancer drug, for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma (STS).
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