FDA Grants Accelerated Approval to Voceryq, First Plasmid DNA Immunotherapy for Recurrent Respiratory Papillomatosis

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