NOVIO announced that FDA has granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), previously known as INO-3107, to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP).

The indication is approved under the accelerated approval program based on demonstrated complete response, defined as no requirement for surgical intervention in the 12 months after treatment in the efficacy population, with continued approval being contingent on verification of clinical benefit in a confirmatory study.¹

What does the data show?

The approval is supported by data from INOVIO’s RRP-001 study, which evaluated Voceryq in 32 adult patients with RRP who had two or more surgeries in the year prior to treatment.^1,2 No additional papilloma surgical excisions were required during the dosing window under the study protocol. 26 Patients required three or more surgeries for papilloma excision in the 12 months before treatment and were included in the efficacy evaluation, with a median of 4.5 surgical excisions in that period.^1,2

Seven of the 26 efficacy-evaluable patients achieved a complete response, requiring no surgical excision of papillomas after 12 months of follow-up, an outcome the company says is not expected as part of the disease’s untreated natural history.¹ All 32 patients completed the study, and the full clinical data was published in Nature Communications and in The Laryngoscope.¹

Kim McClellan, president of the RRP Foundation, frames the approval as a milestone for patient advocacy in drug development. “This new FDA-approved therapy brings us an important step closer to ensuring every RRP patient has access to a non-surgical treatment option that works for them,” she says. “In reaching this milestone, we have shown that patient voices matter in the drug development process.”

What is the safety profile?

Voceryq is found to be well tolerated, with the most common adverse reactions, occurring in more than 5% of patients, including injection site reactions, headache, fatigue, hypertension, nausea, and dizziness.^1,2 Most treatment-related adverse reactions were grade 1 or 2 and transient, and no grade 4 or 5 common adverse events were reported.

INOVIO positions the approval as validation of its DNA medicine platform. “With the approval of Voceryq, we believe our DNA medicine platform has the potential to transform the treatment paradigm for RRP by offering a patient-centric treatment option,” says Jacqueline Shea, PhD, INOVIO’s president and chief executive officer. “Voceryq is designed to deliver what we understand matters most to patients, which is the reduction of the surgical burden caused by RRP. We look forward to delivering Voceryq to the RRP community and believe it has the potential to become a new standard of care for this devastating disease.”

Simon Best, MD, associate professor of otolaryngology at Johns Hopkins University and a lead investigator on the RRP-001 study, points to the clinical rationale for moving away from repeated procedures. “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,” he says. “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.”

What’s next?

FDA is requiring INOVIO to submit a draft protocol for the confirmatory study by the end of 2026, with alignment on a final protocol expected by mid-2027.² Voceryq is approved for use in combination with Cellectra 5PSP, INOVIO’s proprietary DNA medicine delivery device.

INOVIO is expecting to make Voceryq available to order and ship within approximately 60 days, with full field deployment anticipated during the first quarter of 2027.¹ The company is engaging with Syneos Health to support recruitment and deployment of its medical and commercial field teams. The accelerated-approval pathway means commercial uptake will proceed in parallel with continued data generation, leaving the therapy’s long-term standing contingent on how the confirmatory study results compare with this initial 27% complete-response rate.

David Crean, a biotech investor and advisor, told Pharmaceutical Executive that FDA has been layering new mechanisms onto its original PDUFA framework to compress review timelines, including the national priority review voucher program that can shrink review from “10-to-12 months to just one to two.” He adds that FDA is also weighing whether a single Phase III trial should become the default for certain programs, a dynamic that mirrors Voceryq’s own single-study accelerated approval.

Sources

1. INOVIO Announces FDA Accelerated Approval of Voceryq Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP) INOVIO, 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. FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis Food and Drug Administration, October 30, 2026, https://www.fda.gov/news-events/press-announcements/fda-approves-first-plasmid-dna-based-immunotherapy-adults-recurrent-respiratory-papillomatosis