FDA Grants Accelerated Approval to Voceryq, a DNA Immunotherapy for Adults With Recurrent Respiratory Papillomatosis
Voceryq is the second immunotherapy for adult RRP. In 26 evaluable patients, 27 percent needed no surgery for a year. A confirmatory trial is still ahead.
On Oct. 30, the Food and Drug Administration granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, Inovio Pharmaceuticals) for adults with recurrent respiratory papillomatosis (RRP), the first plasmid DNA-based immunotherapy approved in the United States.
RRP is a rare disease in which human papillomavirus types 6 and 11 drive wart-like growths in the airway, most often on the vocal cords. Because the virus persists after excision, patients need repeated surgery, sometimes for years. Inovio's announcement describes the indication as reducing the frequency of surgical papilloma excisions.
What did the trial show?
About one in four evaluable patients avoided surgery for a year. The FDA's announcement says approval rested on an open-label, multicenter trial of 32 adults who had needed two or more laryngotracheal papilloma surgeries in the prior 12 months, including one scheduled at entry. Among 26 patients with at least three baseline surgeries, 7 (27 percent) needed no surgical intervention in the first year after treatment. Inovio gives the 95 percent confidence interval as 12 to 48 percent, and the median number of prior excisions in that group as 4.5.
Patients have standard surgical debulking first, then a nine-week dosing course given by intramuscular injection with the Cellectra 5PSP device, which uses brief electrical pulses (electroporation) to help the plasmids enter cells. The FDA describes surgery frequency as an intermediate endpoint reasonably likely to predict clinical benefit, and Inovio must run a confirmatory trial. The company says it will submit a draft protocol by the end of 2026, aiming for final protocol alignment by mid-2027.
How does it compare with Papzimeos?
It is the second option, and the numbers are not directly comparable. The FDA approved Precigen's Papzimeos (zopapogene imadenovec-drba), an adenoviral vector immunotherapy, on Aug. 14, 2025. Its single-arm pivotal cohort of 35 adults who needed three or more surgeries a year reported complete response, no surgery in the 12 months after treatment, in 51.4 percent (18 of 35). Papzimeos is given as four subcutaneous injections over 12 weeks.
In The Script Pad's side-by-side reading, both products follow debulking with a short course and both define success as a surgery-free year. The differences are the vector (adenovirus versus plasmid DNA), the route (subcutaneous versus intramuscular with electroporation), the evaluable cohort (35 versus 26 patients) and the regulatory path, since Voceryq's approval is explicitly accelerated. Papzimeos's 51.4 percent sits above the upper end of Voceryq's confidence interval, but these were separate single-arm trials with different entry criteria, so that gap is a reason for scrutiny, not a ranking.
Two immunotherapies in 14 months is real progress for a disease managed almost entirely in the operating room. Neither has a randomized comparison yet, and the choice between them will rest on single-arm data for now.
Safety
The most common adverse reactions, each above 5 percent, were injection site reactions, headache, fatigue, hypertension, nausea and dizziness, and most treatment-related reactions were grade 1 or 2, Inovio said. Electroporation can cause brief muscle contractions, transient bleeding at the site and vasovagal reactions, patients should be observed for at least 30 minutes, and use is to be avoided with ipsilateral implanted defibrillators or pacemakers, metal implants or skin abnormalities at the site.
What it means in clinic
Otolaryngologists will now have two immunotherapy options to discuss with adults who need frequent excisions, though Inovio expects ordering and shipping in about 60 days and a full launch in the first quarter of 2027. Pediatric RRP is not covered. For more on how the FDA is adapting review for genetic medicines, see our report on its draft guidance for individualized gene editing.
Reported, fact-checked and edited by The Script Pad's editorial staff. See How we use AI.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
