FDA grants accelerated approval to Voceryq for recurrent respiratory papillomatosis

The U.S. Food and Drug Administration granted accelerated approval on October 30, 2026, to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), indicated for adults with recurrent respiratory papillomatosis. It is the first plasmid DNA-based immunotherapy approved in the United States, according to the agency.

Recurrent respiratory papillomatosis is a rare, chronic disease caused by human papillomavirus types 6 and/or 11; the virus produces wart-like growths that typically appear around the voice box and vocal cords. Symptoms can include hoarseness, chronic cough, and voice changes; severe cases may spread in the respiratory tract and cause difficulty breathing. Surgery removes the growths, but the virus stays in tissue, meaning patients frequently require repeated procedures across many years, and some cases carry a cancer risk over time.

The approval is based on an open-label multicenter trial in 32 adults with RRP. To enroll, patients needed at least two procedures for laryngotracheal papilloma removal during the 12 months before treatment, plus a scheduled surgery at trial entry. Among 26 trial participants who entered with three or more prior surgeries, 7 patients (27%) required no surgical intervention in the first year. The FDA treated the lower surgery frequency as an intermediate endpoint that is reasonably likely to predict benefit, and Inovio Pharmaceuticals must complete post-approval trials to verify that benefit.

Voceryq is a recombinant plasmid DNA therapy that delivers two plasmids into cells: one holds the genetic code for certain HPV proteins, and the other carries an immune-stimulating molecule called IL-12. It is injected intramuscularly with the CELLECTRA 5PSP device, which uses brief electrical pulses to open temporary pores in cell membranes and improve delivery. The most common side effects were injection site reactions, headache, fatigue, high blood pressure, nausea, and dizziness. Reactions tied to electroporation can include brief muscle contractions, temporary bleeding, anxiety, lightheadedness, transient changes in creatine phosphokinase, skin redness, and injection-site pain.

The FDA also granted Voceryq Breakthrough Therapy and Orphan Drug designations. Karim Mikhail, who directs the FDA's Center for Biologics Evaluation and Research, called the approval a “meaningful scientific breakthrough” that could mean fewer surgeries, though the agency also notes that no cure exists and the virus stays in tissue after surgery.

Update, November 1, 2026

Inovio said ordering and shipping of Voceryq are expected to begin about 60 days after the October 30 approval, with full commercial field deployment planned for the first quarter of 2027. The company also said it will submit a draft protocol for the required confirmatory trial to the FDA by the end of 2026, and it expects final protocol alignment by mid-2027.