Policy & Regulation
BioInvent granted FDA orphan designation for follicular lymphoma
19 January 2022 -

Swedish immuno-oncology company BioInvent International AB (STO:BINV) announced on Wednesday that it has received Orphan Drug Designation (ODD) in the United States for its anti-FcyRllB antibody BI-1206 for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma.

The US Food and Drug Administration (FDA) grants orphan status to support the development of medicines for rare disorders that affect fewer than 200,000 people in the US. Benefits of ODD include market exclusivity upon regulatory approval, exemption of FDA biologic licence application fee and tax credits for qualified clinical trials. BI-1206 previously received ODD from the FDA for the treatment of mantle cell lymphoma (MCL) in January 2019.

BI-1206 is BioInvent's lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumours.