The U.S. Food and Drug Administration (FDA) has approved Papzimeos (zopapogene imadenovec-drba) for the treatment of adults with recurrent respiratory papillomatosis (RRP).
RRP is a rare viral disease characterized by benign tumors in the respiratory tract. The tumors can cause a hoarse voice, chronic cough, and difficulty breathing. They may vary in size and grow very quickly, and may grow back even when removed. These tumors rarely become cancerous, but can cause long-term airway and voice complications. RRP is caused by two types of human papillomavirus (HPV), called HPV 6 and HPV 11.
Zopapogene imadenovec is the first and only FDA approved therapy for adults with RRP. It is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen comprising selected regions of HPV 6 and HPV 11 proteins. The therapy is administered via four subcutaneous injections over a 12-week period.
The FDA approval follows results from an open-label, single-arm, pivotal study of zopapogene imadenovec in adults with RRP where the trial met its primary safety and efficacy endpoints. Of total participants, 51% achieved complete response, requiring no surgeries in the 12 months after treatment. The complete responses remained durable for over 12 months. Of the patients who achieved a complete response at 12 months, about 83% showed continued complete response at 24 months.
Additionally, zopapogene imadenovec was well-tolerated with no dose-limiting toxicities and no treatment-related adverse events greater than grade 2.
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To learn more about RRP and other rare respiratory conditions, visit https://checkrare.com/diseases/lung-diseases/