FDA approves first plasmid DNA-based immunotherapy for recurrent respiratory papillomatosis

On 30 October 2026, the U.S. Food and Drug Administration granted accelerated approval for Voceryq, a plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis (RRP). The agency said this was the first approval of a plasmid DNA-based immunotherapy in the U.S. for the rare disease.

The approved product is Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd). It is administered through intramuscular injection using the CELLECTRA 5PSP Device. The FDA said clinical trial data showed Voceryq reduced the frequency of surgical procedures required to remove growths in adult patients with RRP.

The safety and effectiveness of Voceryq was evaluated in an open-label multicenter clinical trial in 32 adults diagnosed with RRP. Eligible patients had two or more surgeries to remove laryngotracheal papillomas in the 12 months prior to treatment. Seven (27%) out of 26 patients who had at least three baseline surgeries did not require any surgery intervention during the first year after treatment.

The FDA based its accelerated approval on an intermediate clinical endpoint reasonably likely to predict clinical benefit. The accelerated approval pathway allows the agency to approve drugs or biologics for serious or life-threatening conditions based on an effect on a surrogate or intermediate clinical endpoint. The manufacturer must conduct post-approval clinical trials to verify and describe Voceryq’s clinical benefit.

Voceryq is a recombinant plasmid DNA-based immunotherapy that delivers two plasmids into cells. One plasmid contains genetic instructions for specific HPV proteins. The other contains IL-12, an immune response-enhancing molecule. The therapy is designed to stimulate the immune system to attack cells infected by the specific types of HPV that cause RRP, types 6 and 11.

The most commonly reported adverse reactions were injection site reactions, headache, fatigue, hypertension, nausea, and dizziness. The FDA granted Voceryq Breakthrough and Orphan Drug designations and granted accelerated approval to Inovio Pharmaceuticals, Inc.