In a recently completed, phase IIb trial in patients with metastatic malignant melanoma, treatment with STA-4783 plus paclitaxel achieved the primary endpoint of increasing progression-free survival.
“Metastatic melanoma is a disease with very limited treatment options for patients and a high mortality rate,” said Safi Bahcall, president and CEO of Synta.
The FDA's fast track program is designed to facilitate the development and expedite the review of new drug candidates that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.
Fast track designation has no impact on the standard of review or on whether the FDA ultimately approves the drug for marketing.