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FDA grants fast track and orphan drug designations to VLS-101 for the treatment of patients with MCL
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On August 31, 2020, the U.S. Food and Drug Administration (FDA) granted fast track and orphan drug designations to VLS-101 for the treatment of patients with mantle cell lymphoma (MCL).1
VLS-101 is an antibody-drug conjugate targeting tyrosine kinase-like orphan receptor 1 (ROR1). A first-in-human, phase I, dose-escalation trial (NCT03833180) is currently investigating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of VLS-101 in patients with relapsed or refractory hematological malignancies, including MCL.
VLS-101 could represent a new therapeutic option for patients with MCL.
- Business Wire. VelosBio announces FDA fast track and orphan drug designations for VLS-101 in patients with mantle cell lymphoma. https://www.businesswire.com/news/home/20200831005097/en/VelosBio-Announces-FDA-Fast-Track-Orphan-Drug. Published Aug 31, 2020. Accessed Sep 01, 2020.
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