FDA approves Voceryq for recurrent respiratory papillomatosis

Clinical Takeaway: Voceryq is a new option to reduce surgical burden in adults with recurrent respiratory papillomatosis (RRP). Counsel patients that some remained surgery-free for a year, but confirmatory studies must verify clinical benefit.

FDA granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), the first plasmid DNA-based immunotherapy approved in the US. The therapy stimulates an immune response against human papillomavirus (HPV) types 6 and 11, the viruses responsible for RRP.

RRP produces recurrent, usually benign wart-like airway growths that can impair speech and obstruct breathing. Surgery has been the mainstay to remove these growths but does not eliminate the underlying infection, leaving many patients facing repeated procedures.

In the RRP-001 trial, seven of 26 patients evaluated for efficacy (27%) required no surgery during the year after treatment. These patients had undergone at least three procedures in the preceding year, with a median of 4.5 surgeries. The findings suggest that treatment can provide a meaningful break from surgery for some patients; they do not establish a cure.

Voceryq is administered after initial surgical debulking of visible papilloma as four intramuscular injections with electroporation three weeks apart using the Cellectra 5PSP device, which applies electrical pulses to facilitate cellular uptake.

Voceryq joins Papzimeos (zopapogene imadenovec-drba) as another option to reduce surgical burden in adults with RRP. Papzimeos has full approval and longer-term follow-up, whereas Voceryq received accelerated approval and requires additional studies to verify clinical benefit. Comparative efficacy has not been established, and no evidence supports a preferred treatment sequence. Choice of therapy should consider differences in administration, with Voceryq delivered by device-assisted intramuscular injection and electroporation and Papzimeos administered subcutaneously, along with each product's distinct safety considerations.

Simon Best, MD, associate professor of otolaryngology at Johns Hopkins University and a lead investigator, described the Voceryq approval as “an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury.”

Sources: FDA. (2026 Oct 30). FDA approves first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis; INOVIO Pharmaceuticals. (2026 Oct 30). INOVIO announces FDA accelerated approval of Voceryq, an immunotherapy to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis (RRP)