FDA Grants Accelerated Approval to First Plasmid DNA-Based Immunotherapy for Recurrent Respiratory Papillomatosis

The U.S. FDA has granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd; Inovio Pharmaceuticals), marking the first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis (RRP). This treatment is indicated to reduce the frequency of surgical papilloma excisions. The approval was based on data from the RRP-001 study, where 27% of patients required no surgery for 12 months, and a confirmatory trial is required.