The FDA has granted accelerated approval to Voceryq, an Inovio immunotherapy intended to reduce repeat operations for adults with recurrent respiratory papillomatosis, or RRP. The October 30 decision adds a treatment option for people whose airway growths keep returning, but further research must confirm its clinical benefit.
Inovio expects ordering and shipping to begin in about 60 days, with a full commercial launch in the first quarter of 2027. The announcement does not establish immediate patient availability.
Why patients need repeated surgery
RRP causes wartlike growths in the respiratory tract, often around the voice box and vocal cords. According to the FDA's announcement, human papillomavirus types 6 and 11 cause the disease. Symptoms can include hoarseness, coughing and breathing difficulties.
Operations remove the growths, but they do not eliminate the underlying infection, so patients may need more procedures. Voceryq is designed to stimulate an immune response against the infected cells. Its approval covers adults; pediatric safety and effectiveness have not been established.
What the trial showed
The prescribing information describes a small, open-label study without a randomized comparison group. Thirty-two adults received treatment and contributed to the safety assessment. The main efficacy analysis covered 26 who had undergone at least three procedures in the preceding year, including the pretreatment operation.
Seven of those 26 patients, or 27%, went without another surgical intervention for 12 months after treatment. The group had a median of 4.5 procedures during the previous year. The label gives a 95% confidence interval of 12% to 48%, reflecting uncertainty around that estimate. The study does not establish how Voceryq compares with another medicine.
Reuters reports that Papzimeos, approved last year, was the first medicine for RRP. Voceryq is the first FDA-approved plasmid DNA-based immunotherapy.
Treatment and the remaining evidence
The labeled course is four doses, three weeks apart, after surgery to remove visible papillomas. A trained clinician administers it using the CELLECTRA 5PSP system, which delivers an injection and brief electrical pulses.
The FDA lists injection-site reactions, headache, fatigue, hypertension, nausea and dizziness among common adverse reactions. Electrical-pulse administration can also cause muscle contractions and other procedure-related effects.
The approval letter requires a confirmatory study involving at least 50 adults and children, with follow-up for at least three years after treatment. Including children in that future study does not expand the current adult approval.
Inovio must submit a draft protocol by December 30, 2026, and a final protocol by June 30, 2027. The FDA sets December 30, 2031, for study completion and August 30, 2032, for the final report.
