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

The FDA has granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), the first plasmid DNA-based immunotherapy, for the treatment of adults with recurrent respiratory papillomatosis (RRP). This rare chronic disease is caused by human papillomavirus (HPV) and often requires repeated surgeries. The new therapy aims to reduce the frequency of surgical papilloma excisions.