The U.S. Food and Drug Administration (FDA) approved Voceryq for adults with recurrent respiratory papillomatosis on Oct. 30, granting accelerated approval based on fewer surgeries while requiring further studies to verify benefit.
Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), developed by Inovio Pharmaceuticals, Inc., is the first immunotherapy using plasmid DNA to receive U.S. approval, the FDA said. The agency regards surgery frequency as an interim indicator that may signal clinical benefit. Inovio must conduct follow-up trials to verify and further describe the treatment’s benefit.
Recurrent respiratory papillomatosis (RRP) is linked to human papillomavirus types 6 and 11 and causes wart-like growths in the airways. Surgery can remove the growths, but the virus may persist in tissue, and patients may need repeated procedures.
In an open-label, multicenter trial of 32 adults, seven patients had no surgery during the year after treatment. They were among the 26 participants who had undergone at least three surgeries at baseline. A separate measure reported in a 2025 Nature Communications study found that 26 of 32 participants had at least one fewer surgery in the year after treatment than in the preceding year.
Voceryq contains two plasmids: one carries instructions for HPV proteins, and the other carries instructions for IL-12, which enhances immune response. The treatment is injected into muscle with the CELLECTRA 5PSP device, which uses brief electrical pulses to aid delivery. The FDA lists injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among the most commonly reported adverse reactions.
The FDA approved Papzimeos, an adenoviral-vector immunotherapy for adults with RRP, in August 2025 and described it as the first immunotherapy for the disease. Voceryq’s first designation refers specifically to its use of plasmid DNA.
The FDA did not specify a timetable or design for the required post-approval trials.
