Voceryq Gains FDA Accelerated Approval for Recurrent Respiratory Papillomatosis

The US Food and Drug Administration (FDA) has granted accelerated approval to doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd (Voceryq) to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP), making it the first plasmid DNA-based immunotherapy approved in the US.1,2

Parent company Inovio announced the approval on October 30, 2026. It is based on complete response data from the open-label, multicenter RRP-001 trial.1,2

"The approval of VOCERYQ is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury,” said Simon Best, Associate Professor of Otolaryngology at Johns Hopkins University and a lead investigator for Inovio’s RRP-001 study. “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."

The approval comes a little more than a year after the FDA approved zopapogene imadenovec-drba (Papzimeos), an adenoviral vector-based immunotherapy, for adults with RRP.3 Voceryq delivers 2 plasmids. One encodes HPV-6 and HPV-11 antigens, and the other encodes the immune-enhancing cytokine interleukin-12 (IL-12).2

Voceryq is given by intramuscular injection with the CELLECTRA 5PSP device, which uses electroporation to help the DNA get into cells.2 The FDA approved the drug and device together.1

What Did the RRP-001 Trial Show for Voceryq?

RRP-001 enrolled 32 adults with RRP who had at least two papilloma excision surgeries in the prior 12 months, including a surgery scheduled at trial entry.2 According to Inovio, all 32 participants completed the study.1

Before the first dose, patients had standard-of-care surgical debulking of visible papillomas. A 9-week dosing regimen followed. Under the protocol, no additional excision surgeries were required during the dosing window.1

The efficacy population was made up of 26 patients with 3 or more surgeries in the 12 months before enrollment. They had a median of 4.5 baseline surgeries (range, 3-8). In this group, 27% (7/26; 95% CI, 12%-48%) achieved a complete response, defined as no surgical intervention through 12 months of follow-up.1,2

RRP-001 had no control arm. The FDA based its decision on the reduction in surgery frequency, an intermediate clinical endpoint it considers reasonably likely to predict clinical benefit.2 According to Inovio, complete responses of this kind are not expected in the untreated natural history of the disease.1

“Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it. Today’s approval represents a meaningful scientific breakthrough: a plasmid DNA-based immunotherapy that harnesses the body’s own immune system to fight the underlying cause of RRP,” said Karim Mikhail, BPharm, MS, Director of the Center for Biologics Evaluation and Research (CBER). “For patients, that could mean fewer surgeries, fewer disruptions, and more time living their lives on their own terms. The FDA is proud to help bring that possibility within reach.”

What Are the Safety Considerations With Voceryq?

The most common adverse reactions, each in more than 5% of patients, were:1,2

• injection site reactions
• headache
• fatigue
• hypertension
• nausea
• dizziness

Inovio reported most treatment-related reactions were grade 1 or 2 and transient. No grade 4 or 5 common adverse events occurred.1

The label’s warnings and precautions include injection site reactions, and Inovio advises monitoring patients for at least 30 minutes after each treatment.¹ Per the FDA, possible effects of electroporation include:2

• brief muscle contractions or tetany
• temporary bleeding at the injection site
• anxiety
• vasovagal reactions
• transient changes in creatine phosphokinase

Clinicians should avoid using the device on the same side as an implanted cardioverter-defibrillator or pacemaker. They should also avoid treatment sites with metal implants or skin abnormalities.1

Continued approval may depend on a confirmatory trial to verify clinical benefit. Inovio described plans to submit a draft protocol to the FDA by the end of 2026, with final protocol alignment expected by mid-2027.1,2

Inovio expects ordering and shipping to begin about 60 days after approval, with full commercial field deployment in the first quarter of 2027. Voceryq has FDA Orphan Drug and Breakthrough Therapy designations. Under its development name, INO-3107, it also has European Commission Orphan Drug designation.1,2

References

1. INOVIO Pharmaceuticals. INOVIO announces FDA accelerated approval of VOCERYQ, an immunotherapy to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP). Published October 30, 2026. Accessed October 30, 2026. https://ir.inovio.com/news/news-details/2026/INOVIO-Announces-FDA-Accelerated-Approval-of-VOCERYQ-an-Immunotherapy-to-Reduce-the-Frequency-of-Surgery-in-Adults-with-Recurrent-Respiratory-Papillomatosis-RRP/default.aspx

2. US Food and Drug Administration. FDA approves first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis. Published October 30, 2026. Accessed October 30, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-plasmid-dna-based-immunotherapy-adults-recurrent-respiratory-papillomatosis

3. US Food and Drug Administration. FDA approves first immunotherapy for recurrent respiratory papillomatosis. Published August 14, 2025. Accessed October 30, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis