FDA Fast Track designation for evofosfamide for treatment of patients living with advanced pancreatic cancer

Merck has announced that the US Food and Drug Administration (FDA) 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 tumour hypoxic conditions, a feature of many solid tumours. The compound, currently in Phase III trials, is being developed in collaboration with Threshold Pharmaceuticals. 

This is the second Fast Track designation for evofosfamide

“Merck is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat,” said Luciano Rossetti, Head of Global Research and Development of Merck’s biopharmaceutical business, Merck Serono. “Many patients with pancreatic cancer present with advanced, inoperable tumours, 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 programme for Merck Serono.”

Threshold Pharmaceuticals received the first Fast Track designation for the development of evofosfamide in combination with doxorubicin for the treatment of advanced soft tissue sarcoma in November 2014.

“We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold Pharmaceuticals. “Evofosfamide is currently being studied in patients with pancreatic cancer in the MAESTRO Phase III study, and based on current projections, we expect that the number of protocol-specified events for the trial may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter.”

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 that demonstrate the potential to address unmet medical needs.