FDA grants accelerated approval to Voceryq for recurrent airway growths

Why repeated surgery matters

RRP is a rare, chronic disease caused by human papillomavirus (HPV) types 6 and/or 11. Wart-like growths develop in the airways, often near the voice box and vocal cords. Surgery removes these growths, but they can return, creating a need for repeated procedures.

Sources for this section: FDA — Accelerated approval of Voceryq for adults with recurrent respiratory papillomatosis

An immune-based approach

Voceryq is a plasmid DNA-based immunotherapy designed to prompt an immune response against HPV types 6 and 11. The recent news is the FDA decision: the primary study was published in Nature Communications on February 12, 2025.

Sources for this section: FDA — Accelerated approval of Voceryq for adults with recurrent respiratory papillomatosis, Nature Communications — DNA immunotherapy for recurrent respiratory papillomatosis: phase 1/2 study of INO-3107, FDA — Voceryq prescribing information, revised October 2026; approval October 30, 2026

What the evidence shows

RRP-001 (NCT04398433) was an open-label, single-arm, multicenter trial involving 32 adults who had needed at least two surgeries during the previous year. The FDA label's efficacy analysis included 26 adults with at least three baseline surgeries.

Seven of those 26 adults (27%) needed no surgery during the first 12 months after treatment. This percentage refers to that subset, not all 32 participants. The study compared surgery frequency with each participant's previous year, without a randomized, parallel untreated group.

Sources for this section: FDA — Accelerated approval of Voceryq for adults with recurrent respiratory papillomatosis, Nature Communications — DNA immunotherapy for recurrent respiratory papillomatosis: phase 1/2 study of INO-3107, FDA — Voceryq prescribing information, revised October 2026; approval October 30, 2026

Approval still requires confirmation

Accelerated approval uses an intermediate endpoint reasonably likely to predict clinical benefit. Post-approval trials must verify and describe that benefit. Reported adverse reactions include injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness. Electroporation, the accompanying electrical-pulse procedure, can also cause procedural reactions.

Sources for this section: FDA — Accelerated approval of Voceryq for adults with recurrent respiratory papillomatosis, FDA — Voceryq prescribing information, revised October 2026; approval October 30, 2026