FDA
Papzimeos OK’d for recurrent respiratory papillomatosis
Brand name: Papzimeos
Generic name: zopapogene imadenovec-drba
Manufacturer: Precigen
Approval date: August 14, 2025
FDA approved Papzimeos (zopapogene imadenovec-drba), a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adults with recurrent respiratory papillomatosis (RRP).
RRP is a rare, chronic disease caused by persistent human papillomavirus (HPV) 6 or 11 infection, leading to the growth of benign tumors in the respiratory tract, most commonly the larynx. The disease is associated with significant morbidity, including voice changes, breathing difficulties, and airway obstruction. There are currently no approved medical therapies that eliminate the need for repeated surgical procedures.
Efficacy
Approval was based on results from a single-arm, open-label trial evaluating Papzimeos in adult patients with RRP who required three or more surgeries per year. Patients received four SC injections of Papzimeos over 12 weeks following surgical debulking (reduction) procedures.
In the pivotal portion of the study, 51.4% of patients (18/35) achieved a complete response—defined as no need for surgical intervention in the 12 months following treatment. Follow-up data showed that durable responses were maintained in most patients through two years, with a strong correlation between clinical benefit and the induction of HPV 6/11-specific T cells.
Safety
Safety profile was favorable, with most treatment-emergent adverse events being mild to moderate. No dose-limiting toxicities were observed, and no treatment-related serious adverse events were reported.
Sources:
FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis. [News release]. 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-immunotherapy-recurrent-respiratory-papillomatosis
Precigen announces full FDA approval of Papzimeos (zopapogene imadenovec-drba), the first and only approved therapy for the treatment of adults with recurrent respiratory papillomatosis. [News release]. 2025. https://investors.precigen.com/news-releases/news-release-details/precigen-announces-full-fda-approval-papzimeos-zopapogene
Papzimeos (zopapogene imadenovec-drba) [package insert]. Precigen. https://precigen.com/papzimeos-prescribing-information.pdf Revised August 2025. Accessed August 18, 2025.