US regulators have granted Fast Track status to Merck KgaA and Threshold Pharmaceuticals’ experimental pancreatic cancer drug evofosfamide (previously TH-302).
In theory, Fast Track status should speed up review of the drug - which is given alongside gemcitabine and is intended for previously untreated patients with metastatic or locally advanced unresectable forms of the disease - and indicates that it has the potential to address unmet medical needs.
Evofosfamide is a hypoxia-activated prodrug currently in late-stage trials for both pancreatic cancer and soft tissue sarcoma, for which it already carries fast track status in the US. The drug is also in earlier trials for other solid tumours and blood malignancies.
Merck and Threshold entered a co-development deal evofosfamide back in 2012, potentially worth more than $500 million to the latter firm.