RRP Foundation position statement.1,2
There’s long been a need for a novel treatment approach for RRP
About recurrent respiratory papillomatosis (RRP)
RRP, a rare, chronic viral infection, is a debilitating disease primarily caused by human papillomavirus infection (HPV) 6 or HPV 11. RRP is characterized by the recurrent growth of papillomas in the upper and lower respiratory tracts that can lead to severe voice disturbance, compromised airway, and recurrent post-obstructive pneumonia.3-6
Some of the most common symptoms of RRP are dysphonia, chronic cough, and dyspnea. Papillomas are recurrent, benign tumors that often affect the vocal cords, subglottis, and epiglottis, but over time can spread to the other respiratory sites, including the trachea, bronchi, and lungs, where they can be fatal.4,6-8
An estimated
~27,000
ADULTS IN THE US
are currently living
with RRP.9
Surgeries for RRP may come with significant limitations
Historically, management for RRP has consisted of repeated laser ablation and surgical excision of papillomas to alleviate symptoms. Due to reactivation of the latent HPV virus in remaining or adjacent tissues, papillomas may recur and require multiple debulking procedures.5,6
These debulking procedures may offer temporary relief, but don’t prevent regrowth of papillomas—and multiple procedures are often required throughout a patient’s lifetime.4
Even in the hands of the most skilled surgeon, every surgical intervention carries a significant risk of iatrogenic laryngeal injury (ILI), which may result in permanent, irreversible damage.2,4
Repeat surgeries can be a challenge for patients4,10
SURGICAL BURDEN
- On average, adult patients with RRP undergo a mean of 13.5 surgical procedures throughout their lives3*
- Some patients may undergo hundreds of surgeries over their lifetimes6
- General anesthesia poses cumulative risk in repeated procedures. It may be associated with postoperative respiratory complications and residual neuromuscular weakness that can cause airway obstruction11,12
In a cohort of patients with RRP (n=17).3
SURGICAL RISK
- 97% of patients with RRP who have undergone 10+ surgical procedures experienced ILI4†‡
- ILI occurs in 67% of patients with RRP and often necessitates additional surgeries to address4‡§
- Every surgery increases the risk of ILI by 32%4‡§
In a cohort of patients with RRP (n=60).4
STUDY DESIGN: Chart review of 199 patients with RRP seen at a tertiary care academic hospital from January 2002 to December 2022.4
In a cohort of patients with RRP (n=199).4
Adjuvant therapies not approved for RRP are sometimes used but don’t address the root cause, so they may only provide inconsistent benefits.6,13
In an FDA listening session, it was shared that any reduction in the number of surgeries is a meaningful outcome for patients with RRP.10
It’s time to advance the standard of care1,2
PAPZIMEOS is changing the treatment landscape as the first immunotherapy that targets the root cause of RRP.1,6
Discover the PAPZIMEOS MOAINDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Indication and Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
Please see full Prescribing Information.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Indication and
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
Please see full Prescribing Information.
INDICATION
PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy indicated for the treatment of recurrent respiratory papillomatosis in adults.
Important Safety Information
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Injection-Site Reactions: Injection-site reactions have occurred with PAPZIMEOS injection. Monitor patients for local site reactions for at least 30 minutes after the initial treatment.
Thrombotic Events: Thrombotic events may occur following administration of adenoviral vector-based therapies. Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5% of patients) in PAPZIMEOS-treated patients were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
USE IN SPECIFIC POPULATIONS
Pregnancy: There are no available data with PAPZIMEOS in pregnant women.
Lactation: There is no information available on the presence of PAPZIMEOS in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PAPZIMEOS and any potential adverse effects on the breastfed child from PAPZIMEOS or from the underlying maternal condition.
Pediatric Use: The safety and effectiveness of PAPZIMEOS have not been established in pediatric patients.
Geriatric Use: Clinical studies of PAPZIMEOS did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
Please see full Prescribing Information.
- References:
- PAPZIMEOS. Package insert. Precigen, Inc; 2025.
- Best SR, Friedman AD, Rosen CA, et al. Recurrent Respiratory Papillomatosis Foundation position statement on the management of adults with RRP. Laryngoscope. 2026;136(suppl 4):S7–S17. doi:10.1002/lary.70379
- Ovcinnikova O, Engelbrecht K, Verma M, Pandey R, Morais E. A systematic literature review of the epidemiology, clinical, economic and humanistic burden in recurrent respiratory papillomatosis. Respir Res. 2024;25(1):430. doi:10.1186/s12931-024-03057-w
- So RJ, Hillel AT, Motz KM, Akst LM, Best SR. Factors associated with iatrogenic laryngeal injury in recurrent respiratory papillomatosis. Otolaryngol Head Neck Surg. 2024;170(4):1091-1098. doi:10.1002/ohn.629
- So RJ, McClellan K, Best SR. Recurrent respiratory papillomatosis: quality of life data from an international patient registry. Laryngoscope. 2023;133(8):1919-1926. doi:10.1002/lary.30401
- Norberg SM, Valdez J, Napier S, et al. PRGN-2012 gene therapy in adults with recurrent respiratory papillomatosis: a pivotal phase 1/2 clinical trial. Lancet Respir Med. 2025;13(4):318-326. doi:10.1016/S2213-2600(24)00368-0
- Ouda AM, Elsabagh AA, Elmakaty IM, et al. HPV and recurrent respiratory papillomatosis: a brief review. Life (Basel). 2021;11(11):1279. doi:10.3390/life11111279
- Fortes HR, von Ranke FM, Escuissato DL, et al. Recurrent respiratory papillomatosis: a state-of-the-art review. Respir Med. 2017;126:116-121. doi:10.1016/j.rmed.2017.03.030
- Data on file. Precigen, Inc.
- Recurrent respiratory papillomatosis patient-led FDA listening session. Recurrent Respiratory Papillomatosis Foundation. Published October 27, 2022. Accessed March 18, 2025. https://rrpf.org/wp-content/uploads/2023/01/RRPF-FDA-Listening-Session-Summary_FINAL_1.24.23-1.pdf
- Motz KM, Hillel AT. Office-based management of recurrent respiratory papilloma. Curr Otorhinolaryngol Rep. 2016;4(2):90-98. doi:10.1007/s40136-016-0118-0
- Cammu G. Residual neuromuscular blockade and postoperative pulmonary complications: what does the recent evidence demonstrate? Curr Anesthesiol Rep. 2020;10(2):131-136. doi:10.1007/s40140-020-00388-4
- Alanazi A, Karas AF, Husain IA. Recurrent respiratory papillomatosis: an update. Int J Head Neck Surg. 2022;13(1):1-7. doi:10.5005/jp-journals-10001-1514