Merck KGaA announced that the Food and Drug Administration (FDA) has granted Fast Track status to evofosfamide 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 that is thought to be activated under severe tumor hypoxic conditions. The FDA had previously granted evofosfamide both Orphan Drug designation and Fast Track status for the treatment of soft tissue sarcoma and pancreatic cancer.

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Evofosfamide is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin vs. doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), and the other in combination with gemcitabine vs. gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Evofosfamide is also being investigated in a Phase 2 trial for the treatment of non-squamous non-small cell lung cancer (NSCLC), and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

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