FDA Fast Tracks Merck KGaA’s Pancreatic Cancer Candidate

The US Food and Drug Administration (FDA) has granted Fast Track designation to Merck KGaA and partner Threshold Pharmaceuticals’ investigational pancreatic cancer drug.

The companies won Fast Track status for the development of evofosfamide, administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide, previously known as TH-302, is an investigational drug thought to be activated under severe tumor hypoxic (low oxygen) conditions, a feature of several solid tumors.

“Merck KGaA, Dermstadt, Germany, 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 the biopharmaceutical business of Merck KGaA, Dermstadt, Germany. “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 facility the timely development of this high-priority program for the biopharmaceutical business of Merck KGaA, Dermstadt, Germany.”

In 2012, Merck licensed the drug from Threshold. It is now in Phase III development for the treatment of advanced pancreatic cancer. In addition to Fast Track designation, the FDA also granted evofosfamide Orphan Drug designation for the treatment of soft tissue sarcoma and pancreatic cancer. The drug is also being tested in a Phase II trial in non-squamous non-small cell lung cancer (NSCLC) and earlier-stage trials in other solid tumors and hematological malignancies.

“We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer,” said Barry Selick, PhD, Chief Executive Officer of Threshold Pharmaceuticals. “Evogosfamide is currently being studies in patients with pancreatic cancer in the MAESTRO Phase 3 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.”

Pancreatic cancer is the 12th most common cancer worldwide, and the seventh most common cause of cancer-related death, accounting for four percent of deaths. Pancreatic cancer is a relatively uncommon, but lethal cancer, with a low survival rate. About 93-95 percent of patients die from their disease within five years. Over the past 30 years, there has been little improvement seen in survival of patients and there remain limited treatment options for pancreatic cancer. The only curative approach is surgery, however roughly 80-85 percent of patients present with advanced, inoperable disease. For this patient population, the aim of treatment is prolongation of survival and palliation of symptoms.

Source: Merck KGaA

Last updated: 5/12/15; 4:35pm EST

 

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