Voceryq is designed to help the immune system fight the HPV types that cause RRP. In a small clinical trial, some adults went a year without needing surgery to remove growths.
What is RRP?
Recurrent respiratory papillomatosis, or RRP, is a rare, long-term disease caused by certain types of human papillomavirus (HPV), usually HPV-6 or HPV-11. It can affect both children and adults.
The virus causes small, wart-like growths called papillomas to form in the breathing passages, most often near the voice box and vocal cords. The growths can cause a hoarse voice, coughing or changes in the voice. If they block the airway or spread farther down the respiratory tract, they can make breathing difficult.
There is no cure for RRP. Until now, treatment has mainly involved repeated surgeries to remove the growths. Surgery can improve symptoms and open the airway, but it does not remove the virus from the tissue, so the growths may return. In rare cases, RRP can become cancerous.
On October 30, 2026, the U.S. Food and Drug Administration (FDA) approved Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with RRP. It is the first approved plasmid DNA-based immunotherapy in the United States. The approval gives adults a treatment option in addition to surgery; it does not mean surgery will no longer be needed, and the approval does not cover children.
How is Voceryq intended to work?
Voceryq is designed to help the body’s immune system recognize and attack cells infected with HPV-6 or HPV-11. It contains genetic instructions for HPV proteins and a substance called interleukin-12, which can support an immune response.
The treatment is given as an injection into a muscle using a device that delivers brief electrical pulses. These pulses temporarily help the treatment enter the body’s cells. The FDA describes Voceryq as an immunotherapy that targets the cause of RRP, rather than simply removing the growths.
What did the study find?
The FDA’s approval was based on an open-label trial—meaning participants and researchers knew the treatment being given—involving 32 adults with RRP. Participants had needed at least two surgeries in the year before treatment, including a surgery planned when they entered the study.
Among the 26 participants who had needed at least three surgeries before treatment, 7 (27%) did not need surgery during the first year after receiving Voceryq. This suggests the treatment may reduce the need for procedures for some people. It did not eliminate the need for surgery for everyone.
The FDA granted accelerated approval based on a reduction in the number of surgeries. This is an intermediate measure that the agency considers reasonably likely to predict clinical benefit. The manufacturer must conduct further studies after approval to confirm and better describe the treatment’s benefits.
Possible side effects
Commonly reported side effects included reactions where the injection was given, headache, tiredness, high blood pressure, nausea and dizziness. The electrical-pulse procedure can also cause temporary muscle contractions, bleeding or redness at the injection site, pain, anxiety or lightheadedness.
Patients should discuss the potential benefits, risks and treatment process with an RRP specialist. Voceryq is a new option for adults, but ongoing monitoring and other care—including surgery when needed—may still be part of treatment.
