FDA grants Orphan Drug Designation to BI-1206 for patients with previously treated MCL

On 30 January 2019, BI-1206, a monoclonal antibody that selectively binds to CD32B in B cells, was granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL).

The Orphan Drug Designation granted by the FDA occurs as BI-1206 is currently in a dose-escalation, consecutive-cohort, open-label phase I/IIa trial (NCT03571568). This trial is evaluating BI-1206 in combination with rituximab in patients with R/R B cell non-Hodgkin lymphoma, including MCL, follicular lymphoma and marginal zone lymphoma.

According to the drug manufacturers, the Orphan Drug Designation granted to BI-1206 by the FDA could provide evidence “to support the use of BI-1206 in combination with rituximab”, which would provide a future treatment option for patients with MCL.

  1. PR Newswire. BioInvent receives FDA orphan designation for BI-1206 for mantle cell lymphoma. [Accessed 2019 Feb 07]
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