The Priority Review

Approvals Brief

FDA approves first plasmid DNA-based immunotherapy for adults with RRP

The FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis, a rare disease caused by HPV. In an open-label multicenter trial of 32 adults, 27% of patients who had at least three baseline surgeries did not require any surgery during the first year after treatment.

Primary source

FDA approval notification, October 30, 2026

FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis

Read the source: FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis fda.gov

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