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FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer
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The FDA has granted fast track designation for the development of evofosfamide for the treatment of metastatic or locally advanced unresectable pancreatic cancer in patients who were previously untreated, the manufacturer announced today.
Evofosfamide (previously TH-302, Merck KGaA) is an investigational hypoxia-activated prodrug being developed in collaboration with Threshold Pharmaceuticals after a global license and co-development agreement in February 2012, according to the release. The compound is administered in combination with gemcitabine for the indication of pancreatic cancer and is thought to be activated under severe tumor hypoxic conditions.
“We are pleased that evofosfamide has been granted fast track status for the treatment of patients living with pancreatic cancer,” Barry Selick, PhD, CEO of Threshold Pharmaceuticals, said in the release. “Evofosfamide is currently being studied 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.”
The FDA granted the first fast track designation for the development of evofosfamide in combination with doxorubicin for advanced soft tissue sarcoma in November, the release said. The FDA and the European Commission also have granted evofosfamide orphan drug designation for the treatment of soft tissue sarcoma and pancreatic cancer, and phase 3 trials for both indications are currently being conducted under special protocol assessment agreements with the FDA. Phase 2 trails also are underway for nonsquamous non–small cell lung cancer and earlier-stage trials are underway for other solid tumors and hematological malignancies, the release said.
“Merck KGaA, Darmstadt, Germany, is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat,” Luciano Rossetti, head of global research and development of the biopharmaceutical business of Merck KGaA, said in the release. “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 … will help to facilitate the timely development of this high-priority program.”
Evofosfamide has not been approved for use in the United States, Europe, Canada or elsewhere, and its safety or efficacy has not yet been proven, the release said.
Disclosure: Rossetti is an employee of Merck KGaA. Selick is an employee of Threshold Pharmaceuticals.