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FDA grants fast track designation to TH-302 for metastatic soft tissue sarcoma
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The FDA granted fast track designation to TH-302 as a potential treatment for previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma, the drug’s manufacturer announced.
TH-302 (Threshold Pharmaceuticals) becomes activated under severe tumor hypoxic conditions, common in solid tumors due to irregular vasculature that provides an insufficient blood supply, according to a press release issued by the company.
“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,” Barry Selick, PhD, CEO of Threshold, said in a press release. “Our ongoing phase 3 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 [new drug application] review process. Currently, we anticipate the primary analysis of overall survival of the phase 3 trial to be conducted in the first quarter of 2016.”
The FDA based its decision on preliminary data from a randomized phase 3 trial designed to assess efficacy and safety of TH-302 combined with doxorubicin vs. doxorubicin alone in 640 previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma.
The primary endpoint of the trial is OS, with secondary endpoints including PFS, overall response rate, pharmacokinetics and safety.
Patients were randomly assigned doxorubicin alone or TH-302 300 mg/m2 administered intravenously on days 1 and 8 with doxorubicin 75 mg/m2 administered on day 1 of each 21-day cycle. After six cycles of therapy, patients with stable and/or responding disease could receive maintenance monotherapy with TH-302 adhering to the same dosing schedule, 300 mg/m2 administered on days 1 and 8 of each 21-day cycle.