The United States Food and Drug Administration has granted accelerated approval to Voceryq, a plasmid DNA immunotherapy for adults with recurrent respiratory papillomatosis. The approval, announced on 30 October 2026, covers the treatment as a way to reduce the frequency of surgery in adults with the condition. Inovio Pharmaceuticals, the company behind the product, said the decision gives it its first approved product in the United States. The condition causes growths in the airways, and patients often need repeated surgery to remove them.
Voceryq was previously known as INO-3107, with generic name doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd. The agency approved Voceryq under its accelerated approval pathway, which allows approval based on an intermediate clinical endpoint that is reasonably likely to predict clinical benefit. Continued approval may depend on a confirmatory study that verifies the clinical benefit. Inovio said it plans to submit a draft protocol for that study by the end of 2026 and to finalise the study design by mid-2027.
What Voceryq is and how it is given
Voceryq targets human papillomavirus types 6 and 11, the types linked to the root cause of the condition in these patients. It delivers two plasmids. One encodes antigens for HPV-6 and HPV-11. The other encodes interleukin-12, a cytokine that helps strengthen the immune response. The aim is for the immune system to respond to the viral antigens and reduce the need for repeated surgical removal of papillomas.
Voceryq is given by intramuscular injection with the CELLECTRA 5PSP device, which uses electroporation, a method that helps the DNA enter cells. The Food and Drug Administration approved the drug and the device together. Inovio said the product is the first plasmid DNA based immunotherapy approved in the United States, and the first DNA medicine approved by the agency. It had earlier received Orphan Drug and Breakthrough Therapy designations from the agency, and Orphan Drug designation from the European Commission under INO-3107.
The approval follows the approval, a little more than a year earlier, of Papzimeos, an adenoviral vector based immunotherapy for adults with the same condition. Inovio chief executive Jacqueline Shea told Reuters that Voceryq differs from Papzimeos because it is DNA based, while Papzimeos uses a modified virus to trigger an immune response.
What the Voceryq trial showed
The approval rests on complete response data from the open label, multicentre RRP-001 trial. The trial enrolled 32 adults who had at least two papilloma excision surgeries in the prior 12 months, including a surgery scheduled at trial entry. All 32 participants completed the study, according to Inovio. Before the first dose, patients had standard surgical debulking of visible papillomas. A nine week dosing regimen followed, and no additional excision surgeries were required during the dosing window under the protocol.
The efficacy population was made up of 26 patients who had three or more surgeries in the 12 months before enrolment. They had a median of 4.5 baseline surgeries, with a range of three to eight. In this group, 27 percent, or seven of 26 patients, achieved a complete response, defined as no surgical intervention through 12 months of follow up. The reported 95 percent confidence interval was 12 percent to 48 percent. The trial had no control arm, and Inovio said complete responses of this kind are not expected in the untreated natural history of the disease.
Simon Best, associate professor of otolaryngology at Johns Hopkins University and a lead investigator for the study, said the approval was an important step for quality of life, because every surgery carries a risk of laryngeal injury. He said: “I believe it is in the best interest of RRP patients that the standard of care quickly transition away from surgical interventions to immunotherapy after RRP is diagnosed.” Karim Mikhail, director of the Center for Biologics Evaluation and Research, said adults with the condition often face a repeated cycle of surgery, and that Voceryq could mean fewer surgeries.
Voceryq safety, availability and next steps
The most common adverse reactions, each seen in more than 5 percent of patients, were injection site reactions, headache, fatigue, hypertension, nausea and dizziness. Inovio reported that most treatment related reactions were grade 1 or 2 and transient, and that no grade 4 or 5 common adverse events occurred. The label warnings include injection site reactions, and Inovio advises monitoring patients for at least 30 minutes after each treatment.
Clinicians should avoid using the device on the same side as an implanted cardioverter defibrillator or pacemaker, and should avoid treatment sites with metal implants or skin abnormalities. Inovio expects Voceryq to be available to order and ship in about 60 days, with commercial launch planned for early 2027. The confirmatory study remains the next formal step, with a draft protocol due by the end of 2026 and final protocol alignment expected by mid-2027.