What Is Papzimeos, and Why Does It Matter?
Papzimeos (zopapogene imadenovec-drba) is a new type of immunotherapy approved to treat adults with recurrent respiratory papillomatosis (RRP). RRP is a rare condition caused by certain types of human papillomavirus (HPV), which leads to non-cancerous growths in the airways. These growths often come back and usually require repeated surgeries to remove them. Papzimeos is the first and only FDA-approved treatment that works by helping your immune system recognize and attack the HPV proteins that cause RRP. It uses a modified virus that doesn’t reproduce in your body to deliver this immune-boosting effect. Until now, surgery was the only option for managing RRP. Papzimeos offers a new way to treat the disease at its source, not just the symptoms.
Why Was It Approved?
Papzimeos was approved based on a study in adults with RRP. In the study, about half of the people treated with Papzimeos didn’t need surgery for at least a year after treatment. Many of them continued to benefit for up to two years. The treatment was generally well tolerated. Most side effects were mild or moderate and included things like redness or pain from the shot, feeling tired, chills, and fever. No serious side effects related to the treatment were reported. The study did not compare Papzimeos to a placebo or other treatments. However, because RRP is a rare disease, the FDA does not always require this type of comparison for approval. The results were considered strong enough to support its use.
What Do I Need to Know?
Papzimeos is given as four shots under the skin over a 12-week period. Before starting treatment, your health care provider will need to remove any visible growths in your airway to reduce the disease to a low level. You may need additional procedures before the third and fourth doses if new growths appear. The most common side effects include pain or redness at the injection site, tiredness, chills, fever, muscle aches, and nausea. These side effects are usually mild to moderate. There is also a risk of blood clots, so your provider will watch for signs like swelling, chest pain, or trouble breathing. Papzimeos is not approved for use in children. It’s also not known if it’s safe to use during pregnancy or while breastfeeding.