MRUS - Merus' Zenocutuzumab wins FDA's fast track status

The FDA grants Fast Track Designation to Merus N.V.'s (MRUS) Zenocutuzumab ((Zeno)) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) that have progressed on standard of care therapy.Merus is currently enrolling patients into the Phase 1/2 eNRGy trial evaluating Zeno monotherapy in patients with NRG1+ cancers, in three cohorts: non-small cell lung cancer; pancreatic cancer; and other solid tumors.The company plans to provide a substantial clinical program update at a medical meeting in Q2 of 2021.Fast Track is a designation granted by the FDA that is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.The FDA had granted Orphan Drug status for Zenocutuzumab for the treatment of pancreatic cancer, in July.

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Merus' Zenocutuzumab wins FDA's fast track status