FDA Approves Immunotherapy for Recurrent Respiratory Papillomatosis

The Food and Drug Administration has approved zopapogene imadenovec-drba (Papzimeos, Precigen, Inc.), a non-replicating adenoviral vector-based immunotherapy, for adult patients with recurrent respiratory papillomatosis (RRP).

RRP is a rare, chronic disease caused by persistent human papillomavirus (HPV) 6 or 11 infection that leads to the growth of benign tumors in the respiratory tract, which may result in voice changes, breathing difficulties and airway obstruction. Traditional treatments have relied primarily on repeated surgical interventions. Previously, there were no FDA-approved therapies that eliminated the need for surgery.

Zopapogene imadenovec-drba is administered via subcutaneous injection and is designed to stimulate an immune response against HPV-infected cells. During the pivotal single-arm, open-label clinical trial, 51.4% of patients who received four injections over 12 weeks achieved a complete response, defined as no need for surgery within 12 months of treatment. Most patients maintained durable responses through two years.