Merck KGaA, Threshold win fast track for pancreatic cancer drug

Last Updated: 2015-05-12

By Reuters Staff

FRANKFURT (Reuters) - Germany's Merck KGaA said that cancer drug evofosfamide, which it is jointly developing with Threshold Pharmaceuticals, won fast track status for the treatment of advanced pancreatic cancer from the U.S. Food and Drug Administration.

Evofosfamide is an investigational hypoxia-activated prodrug that is in clinical development for cancer. Merck licensed in evofosfamide, previously known as TH-302, from Threshold in 2012.

The drug, currently being tested in the third and last phase required for regulatory approval, already has the FDA's fast track designation for treatment of soft tissue sarcoma.

Fast track status means data from clinical trials can be submitted to the FDA on a rolling basis as it becomes available rather than waiting until pivotal studies are completed.