FDA Fast Tracks Threshold Pharmaceuticals' Anticancer Drug

November 12, 2014
Pharmaceutical Technology Editors

Threshold Pharmaceuticals' anticancer drug TH-302 receives FDA Fast Track designation.

Threshold Pharmaceuticals announced on Nov. 11, 2014 that FDA has 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).  Threshold has designed investigational prodrug TH-302 to be activated in hypoxic regions of solid tumors. According to the company, areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood supply as a result of aberrant vasculature. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

FDA’s Fast Track designation facilitates the development and expedites the review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. As part of the Fast Track designation, FDA may consider a "rolling review" of completed sections of the new drug application (NDA) before the complete application is submitted.

"We are pleased that FDA has granted Fast Track status for TH-302 for the treatment of previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma," said Barry Selick, PhD, chief executive officer of Threshold, in a press release. "Our ongoing Phase III trial of TH-302 in these patients is being conducted under a Special Protocol Assessment with the FDA. If successful, the Fast Track designation may provide an added benefit of facilitating the NDA review process. Currently, we anticipate the primary analysis of overall survival of the Phase III trial to be conducted in the first quarter of 2016."

FDA and the European Commission have granted TH-302 Orphan Drug Designation for the treatment of STS and pancreatic cancer. TH-302 is also being investigated in earlier-stage clinical trials of other solid tumors and hematological malignancies, the company reports.

Threshold has a global license and co-development agreement for TH-302 with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the US.

Source: Threshold Pharmaceuticals