FDA approves Voceryq for adults with recurrent respiratory papillomatosis

The FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis (RRP), the agency said. In an open-label trial, seven (27%) out of 26 patients who had at least three baseline surgeries did not require any surgery during the first year after treatment. The approval is the first for a plasmid DNA-based immunotherapy in the U.S., the FDA said, and adults with RRP now have a new therapeutic option.

Why it matters

RRP is a rare, chronic disease in which wart-like growths caused by HPV types 6 and/or 11 form in the airways, the FDA said. Surgery can remove the growths, but there is no cure, and the virus persists in the tissue even after the growths are removed, so patients often need repeated procedures over many years. The FDA described the patient population as having limited treatment options. The agency based this approval on trial data showing Voceryq helps reduce the frequency of surgical procedures needed to remove growths in adult patients with RRP.

Approval and trial results

The FDA announced the approval on October 30, 2026. These are the numbers the agency gave:

Trial size: 32 adults diagnosed with RRP, in an open-label multicenter clinical trial.
Entry criteria: two or more surgeries to remove laryngotracheal papillomas in the 12 months before Voceryq treatment, including a scheduled surgery at trial entry.
Result: 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 said the safety and effectiveness of Voceryq were evaluated in that trial. The release does not state a comparison group.

How Voceryq is given

Voceryq is a recombinant plasmid DNA-based immunotherapy. It delivers two plasmids, small pieces of DNA originally derived from bacteria, into the body's cells. One plasmid contains the genetic instructions for specific HPV proteins and the other an immune response-enhancing molecule called IL-12, the FDA said. The therapy is designed to stimulate the immune system to respond to and attack cells infected by HPV types 6 and 11.

Voceryq is given by intramuscular (IM) injection using a CELLECTRA device. The device delivers the dose and performs electroporation, a technique that uses brief electrical pulses to temporarily and reversibly create pores in the cell membranes so Voceryq can enter the body's cells.

Safety measures

According to the FDA, the most commonly reported adverse reactions to Voceryq were injection site reactions, headache, fatigue, hypertension (high blood pressure), nausea, and dizziness. Adverse effects associated with the electroporation technique may include:

brief muscle contractions or tetany
temporary bleeding at the administration site
anxiety
vasovagal reactions including lightheadedness and dizziness
transient changes in creatine phosphokinase
erythema (skin redness) at the injection site
pain at the injection site

Agency statement and designations

"Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries," said Karim Mikhail, B. Pharm., M.S., Director of the Center for Biologics Evaluation and Research (CBER), in the FDA release.

The FDA granted Voceryq Orphan Drug designation. The FDA granted accelerated approval of Voceryq to Inovio Pharmaceuticals, Inc.

What remains uncertain

The FDA based the accelerated approval on an intermediate clinical measure, the reduced frequency of surgical procedures, rather than on a confirmed clinical benefit. The agency said the manufacturer must conduct post-approval clinical trials to verify and describe Voceryq's clinical benefit.