FDA to fast track Merck's evofosfamide

German life sciences firm Merck KGaA (MRK: DE) says that the US Food and Drug Administration has granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.

Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. The compound, currently in Phase III trials, is being developed in collaboration with the USA’s Threshold Pharmaceuticals (Nasdaq: THLD), which licensed the drug to Merck in 2012, under a deal that provides the US firm with total potential milestone payments are $525 million. Threshold’s shares leapt 15.4% to $4.34 in pre-market trading this morning.

Luciano Rossetti, head of global R&D of the biopharmaceutical business of Merck, commented: "Many patients with pancreatic cancer present with advanced, inoperable tumors, and there are limited treatment options currently available for them. The Fast Track designation for evofosfamide in pancreatic cancer - the second indication for this compound to receive Fast Track designation from the FDA, following the granting of the designation in soft tissue sarcoma - will help to facilitate the timely development of this high-priority program for the biopharmaceutical business of Merck KGaA."