With DNA: Innovative Treatment for Patients with Respiratory Tract Tumors

The U.S. Food and Drug Administration has granted accelerated approval to a new immunotherapy called "Vosirik" for patients with recurrent respiratory papillomatosis, a rare disease that causes benign tumors in the respiratory tract. The approval was based on a clinical trial showing a reduction in the need for surgeries in 27% of patients.

The U.S. Food and Drug Administration has granted accelerated approval to a new immunotherapy called "Vosirik," developed by Inovio Pharmaceuticals, for the treatment of recurrent respiratory papillomatosis in adults. This rare disease is caused by human papillomavirus types 6 and 11, leading to benign tumor growth in the respiratory tract that can cause difficulties in speaking and breathing. The approval, announced on Friday, October 30, was based on an open-label, multicenter clinical trial involving 32 adults who had undergone at least two surgeries in the previous year. Among 26 patients who had at least three surgeries before treatment, 7 patients (27%) did not require any additional surgery during the first year after receiving Vosirik. The FDA considered the reduction in the frequency of surgical interventions a reliable endpoint for accelerated approval, while requiring an additional confirmatory study to verify the long-term therapeutic benefit. Vosirik represents the first product to receive regulatory approval for Inovio and the first plasmid DNA immunotherapy approved by the agency in the United States.