FDA announces approval of first RRP immunotherapy

Aug. 18, 2025

The U.S. Food and Drug Administration announced in a release that they have approved the first immunotherapy for treating adults with respiratory papillomatosis (RRP).

The treatment, Papzimeos, was granted approval to Precigen, Inc. According to the FDA, “Papzimeos is administered via subcutaneous injection and is designed to stimulate an immune response against cells infected with HPV types 6 and 11—the causative agents in RRP.” The immunotherapy could be an alternative to repetitive surgery.

When tested in a trial, Papzimeos prevented the need for surgery in over half of patients who previously needed three or more surgeries annually. Additionally, “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.” No patients experienced severe adverse events due to Papzimeos.

About the Author

Erin Brady

Managing Editor

Erin Brady is Managing Editor of Medical Laboratory Observer.

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