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The FDA granted accelerated approval on Oct. 30, 2026, to Voceryq for adults with recurrent respiratory papillomatosis (RRP), a rare HPV-related airway disease. In a 32-person trial, 7 of 26 patients with at least three surgeries in the prior year had no surgery during the first year after treatment; the company must conduct further trials to verify clinical benefit.
The U.S. Food and Drug Administration on Oct. 30, 2026, granted accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis, a rare disease that causes growths in the airways. The agency described it as the first plasmid DNA-based immunotherapy approved in the United States; trial results supporting approval showed fewer surgical procedures for some patients, while further studies are required to verify the treatment’s clinical benefit.
Voceryq, developed by Inovio Pharmaceuticals, is approved for adults with recurrent respiratory papillomatosis (RRP). The chronic condition is caused by human papillomavirus types 6 and 11, which can produce wart-like growths, or papillomas, in the respiratory tract. The FDA said the therapy is designed to prompt an immune response against cells infected by those HPV types.
The FDA based its accelerated approval on an open-label, multicenter trial of 32 adults. Participants had a history of at least two surgeries to remove laryngotracheal papillomas in the 12 months before treatment, including a scheduled surgery at trial entry. Among the 26 participants who had at least three baseline surgeries, seven (27%) had no surgical intervention during the first year after treatment. That finding does not mean surgery was avoided by all patients, and the trial was small.
Voceryq contains two recombinant plasmids: one carries genetic instructions for specific HPV proteins, and the other carries instructions for interleukin-12 (IL-12), an immune-response-enhancing molecule. It is given by intramuscular injection using the CELLECTRA 5PSP device, which applies brief electrical pulses to help deliver the dose into cells. The FDA listed injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among the most commonly reported adverse reactions.
A New Option Beyond Repeated Surgery
RRP can require repeated procedures because surgery removes visible growths but does not eliminate the underlying virus from tissue. The FDA says papillomas most often form around the larynx and vocal cords and can cause hoarseness, chronic cough and voice changes. In more severe cases, growths can spread through the respiratory tract and make breathing difficult. The agency also notes that RRP carries a risk of becoming cancerous over time in some cases.
The approval adds a treatment intended to address the HPV-infected cells behind the disease, rather than only removing growths after they appear. The trial’s surgery result points to a possible reduction in that burden for some adults, but does not establish that every patient will need fewer procedures or that the disease will be cured. The distinction matters for patients weighing a new therapy against a longstanding pattern of surgical management.
Because the approval is accelerated, the FDA has allowed marketing on the basis of an intermediate endpoint it considers reasonably likely to predict clinical benefit: the frequency of surgery. The agency requires Inovio to conduct post-approval trials to verify and describe that benefit. The approval is therefore a meaningful new option, while the full extent and durability of its benefits remain subject to further evidence.
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How the FDA Reached Its Decision
RRP is a rare, chronic HPV-related disease. The FDA says HPV types 6 and 11 cause the airway growths, most commonly near the voice box. Surgery can remove papillomas, but the virus may remain in tissue, so growths can recur and patients may undergo repeated procedures over many years. The condition is distinct from a routine respiratory infection: its airway growths can affect voice and, in severe cases, breathing.
The FDA granted Voceryq Breakthrough Therapy and Orphan Drug designations. Those designations reflect the agency’s regulatory programs for therapies addressing serious conditions and rare diseases; they do not by themselves establish that a treatment is effective. The approval announcement identifies the small, open-label trial and its surgery-related endpoint as the basis for the accelerated decision.
The therapy’s delivery combines an intramuscular injection with electroporation, which uses short electrical pulses to temporarily create pores in cell membranes and facilitate delivery. The FDA lists possible effects associated with the technique, including brief muscle contractions, temporary bleeding at the administration site, anxiety, faintness or dizziness, temporary changes in creatine phosphokinase, skin redness and injection-site pain.
“Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it.”
— Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research
Benefits Await Post-Approval Testing
The FDA’s announcement does not provide the full trial results, including the overall distribution of surgery counts, the length of follow-up beyond the first year reported, or a comparison with a control group. The study was open-label and involved 32 adults; the agency’s release does not establish how well the results may apply to patients with different disease histories or levels of severity.
Accelerated approval rests on an endpoint the FDA considers reasonably likely to predict clinical benefit, rather than a completed demonstration of that benefit. Further trials must verify and describe how Voceryq affects patients over time. The FDA announcement does not specify the post-approval study design or a deadline for completion. It also does not establish whether treatment prevents recurrence, reduces the risk of cancerous change, or provides lasting benefit beyond the reported first year.
The agency lists adverse reactions and possible effects related to electroporation, but the release does not give detailed rates for each event or comparative safety results. Patients and clinicians will need fuller prescribing information and additional study data to understand the treatment’s benefit-risk profile for individual circumstances.
Further Trials Must Confirm Benefit
Inovio must complete post-approval clinical trials under the accelerated approval pathway to verify and describe Voceryq’s clinical benefit. Those studies are expected to provide evidence beyond the initial surgery-frequency endpoint, although the FDA release does not state a timetable or outline the studies’ specific measures.
Clinicians and patients can also expect additional information to emerge through the treatment’s prescribing materials and follow-up research, including more detail on safety, duration of benefit and which adults are most likely to benefit. The approval permits the treatment to be used for its indicated adult population, but it does not answer those outstanding questions.
Key Questions
What did the FDA approve?
The FDA granted accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis, or RRP. The agency described it as the first plasmid DNA-based immunotherapy approved in the United States.
What is recurrent respiratory papillomatosis?
RRP is a rare, chronic disease caused by HPV types 6 and 11. It produces wart-like growths in the airways, often around the larynx and vocal cords, and can lead to hoarseness, cough or, in severe cases, breathing difficulty.
What trial result supported the approval?
In an open-label trial of 32 adults, 7 of 26 patients with at least three surgeries in the prior year had no surgery during the first year after treatment. This result applies to that subgroup and does not show that all treated patients avoided surgery.
Does the approval mean Voceryq’s benefit is fully confirmed?
No. The approval is accelerated and is based on surgery frequency, an intermediate endpoint the FDA considers reasonably likely to predict clinical benefit. Inovio must conduct further trials to verify and describe the benefit.
What side effects did the FDA report?
The most commonly reported adverse reactions included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The FDA also lists possible effects associated with electroporation, including brief muscle contractions and temporary injection-site effects.
Source: fda.gov
