Threshold Pharma Announces Fast Track Status For Experimental Cancer Drug TH-302

(RTTNews) - Threshold Pharmaceuticals, Inc. (THLD) Tuesday said the U.S. Food and Drug Administration 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 or STS.

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 before the complete application is submitted.

Threshold is conducting this international, randomized pivotal Phase 3 clinical trial in partnership with the Sarcoma Alliance for Research through Collaboration and under a Special Protocol Assessment agreement with the U.S. FDA.