publication date: May. 15, 2015

Fast Track Designation Granted To Merck’s Evofosfamide


FDA granted a Fast Track Designation for 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 tumor hypoxic conditions, a feature of many solid tumors. The compound, currently in phase III trials, is being developed by Merck in collaboration with Threshold Pharmaceuticals Inc.

“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 [in November 2014]—will help to facilitate the timely development of this high-priority program for Merck Serono,” said Luciano Rossetti, head of global research and development of Merck’s biopharmaceutical business, Merck Serono.


Eli Lilly and Company and BioNTech AG entered into a research collaboration to discover novel cancer immunotherapies.

Lilly and BioNTech will work to identify and validate novel tumor targets and their corresponding T cell receptors in one or more types of cancer. These tumor targets and TCRs may then be engineered and developed into selective cancer therapies.

Under the terms of the agreement, BioNTech will receive a $30 million signing fee. For each potential medicine, BioNTech could receive over $300 million in development, regulatory and commercial milestones.

Continue reading 41-19 Fast Track Designation Granted To Merck’s Evofosfamide
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