FDA Grants Accelerated Approval to First DNA-Based Immunotherapy for Recurrent HPV-Related Airway Tumors

The FDA has approved Voceryq, a plasmid DNA immunotherapy, as the first treatment for recurrent respiratory papillomatosis in adults. It works by stimulating the immune system to target HPV-6 and HPV-11 antigens through intramuscular injection with electroporation. In a phase 2 trial, nearly one-third of patients avoided surgery for a full year, marking a significant advance in managing this rare condition.

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Voceryq, marking a milestone as the first DNA-based immunotherapy approved for recurrent respiratory papillomatosis (RRP) in adults. This rare condition, caused by persistent infection with human papillomavirus types 6 and 11, leads to benign but recurrent tumors in the airways, often requiring frequent surgical interventions that carry risks of vocal cord damage and airway obstruction. Voceryq, a plasmid DNA therapy administered via intramuscular injection combined with electroporation, delivers genetic material encoding HPV-6 and HPV-11 antigens along with interleukin-12 to stimulate a targeted immune response. In the pivotal phase 2 RRP-001 trial, 7 out of 26 patients (27%) avoided any surgical excision for an entire year following treatment, a notable outcome given the high burden of repeated procedures in this patient population. The approval was granted under the accelerated approval pathway, which allows earlier access to therapies addressing unmet medical needs based on surrogate endpoints.

The development of Voceryq builds on growing interest in DNA-based vaccines and immunotherapies, particularly for viral diseases where traditional treatments are limited. Prior to this approval, management of RRP relied almost exclusively on surgical removal of papillomas, with no FDA-approved systemic therapy available. The trial data from the RRP-001 study provided sufficient evidence of clinical ben