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The FDA granted accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis, a rare HPV-related airway disease that often requires repeated surgery. The agency said trial data showed fewer surgical procedures were needed; the manufacturer must conduct post-approval studies to verify and describe the therapy’s clinical benefit.
The U.S. Food and Drug Administration on October 30, 2026, granted accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis (RRP), a rare HPV-related disease that causes growths in the airways and can require repeated operations. The FDA said the therapy is the first plasmid DNA-based immunotherapy approved in the United States; its approval is based on evidence that it can reduce the frequency of surgery, while further studies must verify its clinical benefit.
Voceryq is a combination of two recombinant plasmids: one carries genetic instructions for proteins from HPV types 6 and 11, which cause RRP, and the other carries instructions for IL-12, a molecule intended to enhance the immune response. The therapy is designed to prompt the body’s immune system to recognize and attack cells infected with those HPV types. It is given as an intramuscular injection using the CELLECTRA 5PSP device, which applies brief electrical pulses to help deliver the treatment into cells.
The FDA’s decision relied on an open-label, multicenter trial of 32 adults. Participants had undergone at least two surgeries to remove airway growths in the year before treatment, including a scheduled operation at trial entry. Among the 26 participants who had at least three surgeries before treatment, seven, or 27%, had no surgery during the first year after receiving Voceryq. That result describes a subgroup and a one-year period; it does not establish that all patients will avoid surgery or that the disease is cured.
Frequently reported adverse reactions included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The FDA also listed possible effects related to electroporation, including brief muscle contractions, temporary bleeding at the injection site, anxiety, faintness or other vasovagal reactions, temporary changes in creatine phosphokinase, skin redness and injection-site pain. The agency approved Voceryq for Inovio Pharmaceuticals and granted it Breakthrough Therapy and Orphan Drug designations.
A New Option Beyond Repeated Surgery
RRP can return after surgeons remove its growths because the virus persists in the affected tissue. Repeated procedures may be needed over years, and growths can affect the voice or, in severe cases, make breathing difficult. The FDA’s approval gives eligible adults a treatment option intended to target HPV-infected cells, rather than relying only on removing visible growths.
The trial’s surgery findings offer a reason for interest, but they should be read within the limits of the evidence: it was a small, open-label study, and the reported 27% applies only to participants who had at least three operations before treatment. The approval does not mean every patient will need fewer procedures, and the FDA has not described Voceryq as a cure. Its practical benefit will depend in part on whether later studies confirm meaningful improvement for patients.
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Why RRP Often Returns
Recurrent respiratory papillomatosis is a chronic disease caused by HPV types 6 and 11. The virus can lead to papillomas—small, wart-like growths—most often near the larynx and vocal cords. Symptoms can include hoarseness, chronic cough and changes in the voice. If growths spread through the respiratory tract, they can cause breathing problems; the FDA said that in some cases RRP can become cancerous over time.
Surgery can remove the growths but does not eliminate the virus from tissue, which helps explain why patients may need additional procedures. Voceryq’s design is different: the plasmids provide instructions intended to direct an immune response against cells infected by the HPV types associated with RRP. The agency’s approval is accelerated, a pathway for serious conditions that can rely on a surrogate or intermediate endpoint reasonably likely to predict clinical benefit, with post-approval trials required to confirm that benefit.
“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
Questions Awaiting Follow-Up Studies
The FDA’s announcement does not provide the full trial results, including a comparison group’s outcomes or detailed results across all 32 participants. It is also not clear from the release how durable any reduction in procedures may be beyond the reported first year, which patients are most likely to benefit, or whether treatment changes the long-term course of RRP.
Because this is an accelerated approval, the manufacturer must carry out post-approval clinical trials to verify and describe Voceryq’s clinical benefit. The FDA release does not specify the studies’ timelines, enrollment targets or milestones. The approval also does not establish that patients can stop receiving surgery; decisions about care will depend on individual circumstances and clinical evaluation.
Post-Approval Evidence and Patient Use
Inovio must conduct the post-approval studies required under the accelerated approval pathway. Those studies are expected to provide further evidence on whether the treatment’s effect on surgical procedures translates into clinical benefit and to clarify the benefit over time. The FDA’s announcement did not give a schedule for their completion.
Patients and clinicians will also need more information from continued use about how the treatment performs outside the trial and how its possible adverse reactions affect care. For now, the confirmed regulatory development is approval for adults with recurrent respiratory papillomatosis; the extent and durability of benefit remain subjects for follow-up evidence.
Key Questions
What did the FDA approve?
The FDA granted accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis, a disease associated with HPV types 6 and 11.
Does the approval mean Voceryq cures RRP?
No. The FDA said the treatment was shown to reduce the frequency of surgical procedures in trial data. The release does not describe Voceryq as a cure, and the manufacturer must conduct further studies to verify and describe its clinical benefit.
What did the trial report about surgery?
Of 26 trial participants who had at least three surgeries before treatment, seven (27%) had no surgery during the first year after receiving Voceryq. This result applies to that subgroup and period, not to all patients.
What side effects did the FDA list?
Frequently reported reactions included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. The FDA also listed possible effects linked to electroporation, such as brief muscle contractions, temporary bleeding, faintness, temporary creatine phosphokinase changes, skin redness and injection-site pain.
Why is the approval accelerated?
The FDA used an endpoint—the frequency of surgical procedures—that it considered reasonably likely to predict clinical benefit. Post-approval trials are required to verify and describe the treatment’s clinical benefit.
Source: fda.gov
