FDA Approves Voceryq, First Plasmid DNA Immunotherapy for Recurrent Respiratory Papillomatosis

The FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd; Inovio Pharmaceuticals) for adults with recurrent respiratory papillomatosis (RRP).¹ The agency described it as the first plasmid DNA-based immunotherapy approved in the US.¹ Voceryq is indicated to reduce the frequency of surgical papilloma excisions, according to the manufacturer.^2,3

The decision came on the Prescription Drug User Fee Act goal date.^3,4 In December 2025, the FDA said in an acceptance letter that the application did not initially justify accelerated approval eligibility, according to a company release.⁴ The agency also granted Voceryq Breakthrough Therapy and Orphan Drug designations.¹

What Efficacy Data Supported the Voceryq Accelerated Approval?

The approval rests on the RRP-001 study (NCT04398433), an open-label, multicenter phase 1/2 trial in 32 adults with RRP linked to HPV-6, HPV-11, or both.^2,3 Eligible patients had 2 or more surgeries in the 12 months before treatment, including a scheduled surgery at entry.¹ Of 32 patients, 26 had at least 3 baseline surgeries (median, 4.5; range, 3-8) and formed the efficacy population.²

Seven of 26 patients (27%; 95% CI, 12-48) had a complete response, defined as no surgical papilloma excision during 12 months of follow-up.² The company said this outcome is not expected in the natural history of untreated disease, although the release reported neither a control arm nor a P value.² The FDA described the end point as an intermediate clinical end point reasonably likely to predict clinical benefit.¹

Voceryq is given by intramuscular injection with the CELLECTRA 5PSP device, which uses brief electrical pulses to move DNA into cells.¹ The 9-week dosing regimen follows standard surgical debulking of visible papilloma, and no additional surgery is required as part of the dosing.² The agency is requiring post-approval trials to verify and describe clinical benefit.¹

What Are the Safety Findings and Mechanism of Voceryq in RRP?

Voceryq delivers 2 plasmids, 1 encoding HPV-6 and HPV-11 antigens and the other interleukin-12, an immune-enhancing cytokine.^1,2 The design is meant to stimulate an immune response against cells infected with the HPV types responsible for RRP.¹

The most common adverse reactions, with an incidence above 5%, were injection site reactions, headache, fatigue, hypertension, nausea, and dizziness.² Most treatment-related adverse reactions were grade 1 or 2 and transient; no grade 4 or 5 events occurred, and all 32 patients completed the study.²

Electroporation can cause muscle contractions, transient bleeding, and vasovagal reactions.^1,2 Prescribing information calls for monitoring injection sites for at least 30 minutes.² Use should be avoided with ipsilateral implantable cardioverter-defibrillators, pacemakers, metal implants, or skin abnormalities at the site.²

The approval offers a new option for patients facing repeated procedures. “Adults living with recurrent respiratory papillomatosis often face an exhausting and relentless cycle of repeated surgeries, managing their disease, but never truly escaping it,” Karim Mikhail, BPharm, MS, director of the FDA Center for Biologics Evaluation and Research, said in a statement.¹

An investigator on the study also welcomed the decision. “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,” Simon Best, MD, associate professor of otolaryngology at Johns Hopkins University, said in a company news release.²

Inovio must submit a draft confirmatory study protocol to the FDA by the end of 2026 and expects to align on a final protocol by mid-2027.² The company expects Voceryq to be available to order in about 60 days, with full field deployment in the first quarter of 2027.²

References

1. FDA approves first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis. News release. FDA. October 30, 2026. Accessed November 2, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-plasmid-dna-based-immunotherapy-adults-recurrent-respiratory-papillomatosis

2. INOVIO announces FDA accelerated approval of Voceryq, an immunotherapy to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP). News release. Inovio Pharmaceuticals. October 30, 2026. Accessed November 2, 2026. https://www.biospace.com/press-releases/inovio-announces-fda-accelerated-approval-of-voceryq-an-immunotherapy-to-reduce-the-frequency-of-surgery-in-adults-with-recurrent-respiratory-papillomatosis-rrp

3. An open-label multi-center study of INO-3107 with electroporation (EP) in subjects with HPV-6- and/or HPV-11-associated recurrent respiratory papillomatosis (RRP). ClinicalTrials.gov identifier: NCT04398433. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT04398433

4. Jeffries E. FDA questions accelerated approval for RRP therapy. Becker's Hospital Review. December 29, 2025. Accessed November 2, 2026. https://www.beckershospitalreview.com/pharmacy/fda-questions-accelerated-approval-for-rrp-therapy