Papzimeos (zopapogene imadenovec) is recommended as the new first-line treatment for adults with recurrent respiratory papillomatosis (RRP), which affects an estimated 27,000 US adults.
RT’s Three Key Takeaways:
- New First-Line Standard: An expert consensus published in The Laryngoscope recommends the FDA-approved HPV-specific immunotherapy Papzimeos (zopapogene imadenovec) as the new first-line treatment for adults with recurrent respiratory papillomatosis (RRP).
- Shift Away from Repeated Surgery: The guidance marks a major change from decades of surgery-focused management toward treating the underlying HPV 6 or 11 infection to achieve more durable disease control.
- Patient-Centered Management Approach: The recommendations emphasize early therapy, shared decision-making, and multidisciplinary care to reduce surgical risks and improve long-term outcomes for adults living with RRP.
A new expert consensus paper recommends Papzimeos (zopapogene imadenovec) as the new standard of care first-line treatment for adults with Recurrent Respiratory Papillomatosis (RRP), according to Precigen Inc.
The consensus paper, published in The Laryngoscope, is sponsored by the Recurrent Respiratory Papillomatosis Foundation (RRPF) and authored by 16 leading physicians in the field of RRP.
RRP is a rare, debilitating, and potentially life-threatening disease of the upper and lower respiratory tract caused by chronic HPV 6 or HPV 11 infection. RRP can lead to severe voice disturbance, compromised airways, and recurrent post-obstructive pneumonia. Although rare, RRP has the potential for transformation to malignant cancer and can be fatal. It affects an estimated 27,000 adult patients in the US, according to Precigen.
For more than a century, patients with recurrent respiratory papillomatosis have had no approved therapeutic option beyond repeated surgery, an approach that does not address the underlying cause of the disease. This independent, expert-authored consensus paper represents a landmark moment for the RRP community, formalizing a shift away from surgery toward a new standard of care that treats the underlying HPV infection.
The recommendations position HPV-specific immunotherapy, Papzimeos, as the preferred first-line treatment for adults with RRP and are grounded in the collective clinical experience of the authors, a comprehensive review of the published literature, and the availability of Papzimeos, the first and only FDA-approved HPV-specific immunotherapy.
“The speed and agility with which the authors evaluated the evidence and aligned on a recommended first-line treatment and new standard of care for adults with RRP underscores both the unmet need in this disease and the importance of providing patients and physicians with clear, evidence-based guidance following the FDA approval of Papzimeos,” said Helen Sabzevari, PhD, President and CEO of Precigen.
“For physicians, this publication provides critical clarity by establishing a treatment algorithm for RRP that prioritizes early therapy and moves beyond repeated surgical intervention and the cumulative risk of iatrogenic injury,” said Gaetano Bonifacio, MD, Head of Medical Affairs at Precigen. “Importantly, the recommendations reflect the demonstrated safety and efficacy of PAPZIMEOS, including the long-term durability observed in responders, offering patients the potential for lasting disease control. The paper outlines a clear management approach for adults with RRP, recommending HPV-specific immunotherapy, PAPZIMEOS, as the preferred first-line treatment.”
The authors emphasize shared decision-making, early consideration of therapy to avoid the risks associated with repeat surgeries, and a multidisciplinary approach to care. The paper serves as a reference for clinicians caring for RRP as well as an information guide for patients.
“For a disease that has been managed for more than a century without a clearly defined standard of care, this is an exciting and meaningful moment,” said Simon R. Best, MD, Associate Professor of Otolaryngology–Head and Neck Surgery at Johns Hopkins University School of Medicine. “For the first time, there is a clear, evidence-based guideline that defines both the standard of care and first-line therapy for adults with RRP, reflecting broad agreement among leading experts across the United States.”
The consensus paper was developed with direct input from RRPF leadership, including patients and caregivers, and reflects a shared commitment to advancing patient-centered care in RRP. The authors note that the availability of an FDA-approved HPV-specific immunotherapy, Papzimeos, makes it possible for the first time to establish a modern management algorithm focused on durable disease control rather than repeated surgical interventions to relieve symptoms.