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FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis

Today, the U.S. Food and Drug Administration approved Papzimeos (zopapogene imadenovec-drba), a first-of-its-kind non-replicating adenoviral vector-based immunotherapy for the treatment of adult patients with recurrent respiratory papillomatosis (RRP).RRP is a rare, chronic disease caused by persistent human papillomavirus (HPV) 6 or 11 infection, leading to the growth of benign tumors in the respiratory tract, most commonly the larynx. The disease is associated with significant morbidity, including voice changes, breathing difficulties, and airway obstruction. There are currently no approved medical therapies that eliminate the need for repeated surgical procedures.“Randomized trials are no...