On October 30, 2026, the U.S. Food and Drug Administration granted accelerated approval to Voceryq for RRP, or recurrent respiratory papillomatosis, in adults. The treatment is the first plasmid DNA-based immunotherapy approved in the United States. It offers a new option for a rare, chronic disease that can require repeated surgeries to remove airway growths. For related background, see FDA approves rectal cancer immunotherapy for select adults.
The FDA announcement describes evidence of reduced surgical burden, but further trials are required to verify clinical benefit. The approval does not establish a cure.
What Is Recurrent Respiratory Papillomatosis?
RRP is caused by human papillomavirus, specifically HPV types 6 and/or 11. It produces small, wart-like growths called papillomas in the airways. These most often develop around the larynx, or voice box, particularly the vocal cords.
Symptoms can include hoarseness, chronic cough, and voice changes. In severe cases, growths can spread to other parts of the respiratory tract and cause difficulty breathing. The FDA also notes that RRP carries a risk of becoming cancerous over time in some cases.
Surgery can remove the growths, but HPV persists in the tissue afterward. As a result, people with RRP may need repeated procedures over many years. The FDA describes the disease as having no cure.
How Voceryq for RRP Works
Voceryq, whose generic name is doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd, is designed to stimulate an immune response against cells infected with HPV types 6 and 11.
The therapy delivers two plasmids—small pieces of DNA originally derived from bacteria—into the body’s cells. One contains genetic instructions for specific HPV proteins. The other contains instructions for IL-12, a molecule that enhances the immune response.
Voceryq is administered by intramuscular injection using the CELLECTRA 5PSP Device. The device facilitates electroporation: brief electrical pulses temporarily and reversibly create openings in cell membranes to help the treatment enter cells. This is a treatment for adults with RRP, rather than an approval for HPV-related conditions generally.
What the Clinical Trial Found
The FDA evaluated safety and effectiveness in an open-label, multicenter trial involving 32 adults with RRP. Eligible participants had undergone at least two surgeries to remove papillomas in the larynx and trachea during the preceding 12 months, including a scheduled surgery at trial entry.
Among 26 participants who had at least three baseline surgeries, seven, or 27%, required no surgical intervention during the first year after treatment. That result applies to this specified subgroup, not all 32 trial participants.
The FDA based accelerated approval on a reduction in the frequency of surgery, an intermediate clinical endpoint considered reasonably likely to predict clinical benefit. Under this pathway, the manufacturer must conduct post-approval trials to verify and describe the treatment’s clinical benefit.
Reported Side Effects and Treatment Discussions
The most commonly reported adverse reactions were injection-site reactions, headache, fatigue, hypertension, nausea, and dizziness.
The FDA also lists possible effects associated with electroporation, including brief muscle contractions or tetany, temporary bleeding at the administration site, anxiety, and vasovagal reactions involving lightheadedness and dizziness. Other effects include temporary changes in creatine phosphokinase, skin redness, and injection-site pain.
For adults living with RRP, the announcement provides information to discuss with their treating clinician, including the potential to reduce surgery, the reported adverse effects, and the remaining uncertainty requiring follow-up research. Approval alone does not determine whether the treatment is appropriate for an individual.
Frequently Asked Questions
Is Voceryq approved for children with RRP?
No. The FDA announcement specifies approval for adults with recurrent respiratory papillomatosis. It does not announce a pediatric indication.
Does Voceryq eliminate the need for surgery?
Not necessarily. Seven of 26 participants with at least three baseline surgeries needed no surgery during the first year after treatment. That finding does not mean every patient will avoid further procedures.
Why are more clinical trials required?
Voceryq received accelerated approval based on reduced surgical frequency, an intermediate endpoint reasonably likely to predict clinical benefit. The manufacturer, Inovio Pharmaceuticals, must conduct additional trials to verify and describe that benefit.
