Fast Track Approval of cancer drug evofosfamide of Merck KGaA & Threshold Pharmaceuticals

Germany’s Merck KGaA said that experimental 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.

Merck had licensed in evofosfamide, previously known as TH-302, from Threshold in 2012.

The drug attacks body tissue that is short of oxygen supply, a typical characteristic of many tumors because cancerous cells often grow without connecting to the blood vessels around them.

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.

Drug Discovery and Development Pathway – 

Evofosfamide (TH-302) was developed by Threshold Pharmaceuticals Inc. (Threshold). The company is located in South San Francisco, CA, USA.

In 2012, Threshold signed a global license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize eofosfamide in the United States. Threshold is responsible for the development of evofosfamide in the soft tissue sarcoma indication in the United States. In all other cancer indications, Threshold and Merck KGaA are developing evofosfamide together. From 2012 to 2013, Merck KGaA paid 110 million US$ for upfront payment and milestone payments to Threshold. Additionally, Merck KGaA covers 70% of all evofosfamide development expenses.