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FDA grants fast track status for Merck’s pancreatic cancer drug evofosfamide

The US Food and Drug Administration (FDA) has granted fast track designation for Merck's evofosfamide to treat patients living with advanced pancreatic cancer.

PancreaticCancer

The fast track status is for the development of evofosfamide (previously known as TH-302) in combination with gemcitabine to treat these patients.

Evofosfamide is an investigational drug which is being developed in collaboration with Threshold Pharmaceuticals.

The drug is thought to be activated under severe tumor hypoxic (low oxygen) conditions, a feature of many solid tumors.

Merck biopharmaceutical business Global Research and Development head Luciano Rossetti said: "Merck KGaA, Darmstadt, Germany, is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat.

"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, Darmstadt, Germany."

In November last year, Threshold secured the first fast track designation for the development of evofosfamide in combination with doxorubicin to treat advanced soft tissue sarcoma.

Threshold Pharmaceuticals CEO Barry Selick said: "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."

Currently, evofosfamide is being evaluated in two Phase III trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), while the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the Maestro trial).


Image: Advanced pancreatic cancer is second indication to receive FDA fast track status for Merck’s evofosfamide. Photo: © Merck KGaA.