FDA approves first plasmid DNA immunotherapy for adults with recurrent respiratory papillomatosis

The FDA granted accelerated approval to Voceryq for adults with recurrent respiratory papillomatosis (RRP), a rare disease in which human papillomavirus causes wart-like growths in the airways. The agency said it is the first plasmid DNA-based immunotherapy approved in the U.S. Voceryq is designed to prompt an immune response against cells infected with HPV types 6 and 11.

In an open-label multicenter trial of 32 adults, seven (27%) out of 26 patients who had at least three baseline surgeries did not require surgery during the first year after treatment. The FDA said the approval was based on reduced frequency of surgical procedures, an intermediate clinical endpoint reasonably likely to predict clinical benefit. The manufacturer must conduct post-approval clinical trials to verify and describe the benefit.