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Pancreatic Cancer Drug Evofosfamide Wins ‘Fast Track’ Designation

Hypoxia-activated prodrug targets solid tumors

The FDA has granted “fast track” status to the development of evofosfamide (EMD Serono/Threshold Pharmaceuticals), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.

Evofosfamide is an investigational drug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. The compound is currently in phase III trials.

The FDA established the “fast track” designation process to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions and that have demonstrated the potential to address unmet medical needs.

Pancreatic cancer is a relatively uncommon but lethal malignancy. Ranked as the twelfth most common cancer worldwide, it is the seventh most common cause of cancer-related death, accounting for 4% of deaths. With 93% to 95% of patients dying from their disease within 5 years, pancreatic cancer has a low survival rate. Little improvement has been seen in the survival of patients with pancreatic cancer during the past 30 years, and there are limited treatment options for the disease. Surgery remains the only curative approach; however, most patients (80% to 85%) present with advanced, inoperable disease. For this large group of patients who are ineligible for surgery, the aim of treatment is the prolongation of survival and the palliation of symptoms.

Evofosfamide (formerly known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor hypoxic conditions. Areas of hypoxia in solid tumors are due to an insufficient blood-vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Evofosfamide is currently under investigation in two phase III studies: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft-tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer. The FDA has granted evofosfamide an “orphan drug” designation for the treatment of STS and pancreatic cancer. Evofosfamide is also being investigated in a phase II trial for the treatment of non-squamous non–small-cell lung cancer. The compound has not been approved for use in the U.S., Europe, Canada, or elsewhere.

EMD Serono is the U.S. name of the biopharmaceutical business Merck KGaA, based in Darmstadt, Germany.

Source: EMD Serono; May 12, 2015.

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