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Orphan drug designation granted to BI-1206 antibody for the treatment of follicular lymphoma

By Maria Kasimati

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Jan 20, 2022


On January 19, 2022, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to BI-1206, an anti-FcyRllB antibody, for the treatment of follicular lymphoma (FL).1

FL is an indolent B-cell lymphoma that represents 20‒30% of all non-Hodgkin lymphomas (NHL). The agent is currently being investigated in a phase I/II trial in combination with rituximab for the treatment of NHL, which includes patients with FL, mantle cell lymphoma, and marginal zone lymphoma who have relapsed or are refractory to rituximab. Results suggest BI-1206 may help to restore the response to rituximab in patients with few treatment alternatives, especially so for patients with FL.

The monoclonal antibody BI-1206 has also previously received orphan drug designation from the FDA for the treatment of mantle cell lymphoma, an aggressive form of NHL, in January 2019.

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