Recurrent respiratory papillomatosis (RRP) is a rare condition where small, wart-like tumors grow in the airway. These growths are called papillomas. They are usually not cancerous but can lead to serious breathing problems.
The growths can appear anywhere in the respiratory tract, but they most often affect the voice box (larynx) and windpipe (trachea). These growths are also known as laryngotracheal papillomas. The most common symptom of RRP is hoarseness, which can worsen over time. If the growths block the airway, other problems such as coughing, trouble swallowing, or severe breathing problems may happen.
Surgery is the main treatment for RRP, but the papillomas often grow back. Some people need to have frequently repeated surgeries – possibly more than a hundred during their lifetime.
In August 2025, the FDA approved Papzimeos (zopapogene imadenovec-drba) as the first medicine for the treatment of RRP in adults. It is given as a shot under the skin and works by training the immune system to target the virus that causes the papillomas to grow.
Below are common questions and answers about Papzimeos for RRP.
How Does Papzimeos Work for Respiratory Papillomatosis?
Recurrent respiratory papillomatosis (RRP) is caused by certain types of a virus called human papillomavirus (HPV), most often types 6 or 11.
Papzimeos is a type of immunotherapy. It works by helping the immune system recognize and attack cells infected with HPV types 6 or 11, the types that cause RRP.
Papzimeos uses a harmless adenoviral vector (a modified cold virus that cannot cause illness or copy itself) to deliver instructions for making parts of certain HPV proteins. This teaches the immune system to recognize those virus types and attack cells infected with HPV types 6 or 11.
By training the immune system to attack infected cells, Papzimeos may help slow the growth of papillomas in the airway. This may reduce or delay the need for surgeries in adults with RRP.
What Is the Recommended Treatment Schedule for Papzimeos?
Papzimeos is given as a shot by a health care professional. The typical treatment schedule for Papzimeos includes four doses given over a period of 12 weeks.
Here is an example schedule:
- Dose 1: Given after surgery to remove papillomas from your airway
- Dose 2: Given two weeks (or 11-14 days) after dose 1
- Dose 3: Given six weeks after dose 1
- Dose 4: Given 12 weeks after dose 1
Between the third and fourth doses, you may need to have another surgery to remove papillomas to help keep the disease under control. Your health care provider will discuss your treatment schedule with you, including if and when surgery may be needed.
What Happens During Papzimeos Treatment?
Papzimeos is given as a shot under the skin of the upper arm or thigh. Before each dose, let your health care provider know if you have any skin infections, swelling, injuries, or if you recently received another injection in the upper arm or thigh. Your provider will avoid these spots when giving Papzimeos.
As a precaution, you may be monitored for any reactions for at least 30 minutes after your dose.
Avoid touching or scratching the area, and do not touch the dressings or bandages for about 24 hours after each shot. For one to two weeks after each shot, be aware that any dressings used at the injection site may contain small amounts of body fluid. To avoid spreading germs, any dressings should be sealed in a bag before being thrown away. Always wash your hands after handling. Be sure to follow the instructions given by your health care provider.
How Was Papzimeos Studied for Respiratory Papillomatosis?
The effect of Papzimeos on adults with recurrent respiratory papillomatosis (RRP) was studied in a clinical trial. To join this study, people needed to have a diagnosis of RRP and had at least three surgeries in the past year to remove growths from the voice box or windpipe (laryngotracheal papillomas).
A total of 38 people joined the study. Most of them (87%) were White, 3% were Asian, 3% were African American, 3% identified their race as "other," and 5% were of unknown race. Also, 84% identified as non-Hispanic or non-Latino. Everyone received four doses of Papzimeos over a period of 12 weeks. Before the first dose, everyone had surgery to remove growths, and some people also had one surgery to remove new growths during the study (only if needed, as determined by their doctor). Three people received a lower dose of Papzimeos. The other 35 people received a higher dose, and this group was used to measure how well the treatment worked.
The following information describes the 35 people in this group:
- The median age was 49, with ages ranging from 20 to 88. The median refers to the middle value in a set of results.
- 43% were female and 57% were male.
- Everyone had multiple surgeries (ranging from three to 10) in the last year before joining the study. The median number of surgeries was four, including the surgery required before the first dose of Papzimeos.
- Most (66%) were diagnosed with RRP at age 13 years or older, and the rest (34%) were diagnosed as a child (under age 13).
- Most had HPV type 6 (69%) and the rest (31%) had HPV type 11.
- Most (79%) had received the HPV vaccine in the past, and the rest had not.
The main goal of the study was to see how many people could go a full year without needing surgery after completing Papzimeos treatment.
What Are the Benefits of Papzimeos, Based on the Study?
To measure how well Papzimeos worked for adults with RRP, the main goal (primary endpoint) of the study was to see how many people had a complete response, meaning they did not need surgery to remove growths in their airway for 12 months after treatment.
About half (51%) of the 35 people did not need surgery for 12 months after Papzimeos treatment.
These results suggest that treatment with Papzimeos may help reduce the need for surgeries in adults with RRP. Keep in mind that your results may differ from those of the study.
Can Papzimeos Cure Respiratory Papillomatosis?
It is not yet known whether Papzimeos can cure RRP or end the need for surgeries in some people. A study is ongoing to learn about the long-term effects of Papzimeos, including how long people go without needing surgery.
So far, the researchers have reported follow-up results at the two-year mark:
- Of the 18 people who had a complete response at 12 months after Papzimeos treatment, 15 people continued to respond and were still surgery-free at 24 months.
Is There Any Cost Assistance Available for Papzimeos?
A cost assistance program is available from Precigen, the maker of Papzimeos. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. You can contact the drugmaker at 866-827-8180 to connect with a representative for financial support information and other resources.
