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The FDA granted accelerated approval to Voceryq, a plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis (RRP), to reduce the frequency of surgeries to remove airway growths. In a 32-person early-stage trial, 27% of a subgroup with at least three prior-year surgeries had no excisions during 12 months of follow-up; postmarketing trials must verify the clinical benefit.
The FDA has granted accelerated approval to Voceryq, a plasmid DNA-based immunotherapy, to reduce how often adults with recurrent respiratory papillomatosis (RRP) need surgery to remove growths in their airways. The decision offers a medical option for a rare, HPV-related disease that can return after surgery, but the agency will require further studies to verify the treatment’s clinical benefit.
The approval covers doruxapapogene ralaplasmid-lalikinogene sifuplasmid, marketed as Voceryq, for adults with RRP. The FDA based its decision on efficacy data from RRP-001, an open-label phase I/II trial involving 32 patients who had undergone at least two surgeries in the year before enrollment.
Among the 26 participants who had at least three surgeries in the preceding 12 months, 27% had a complete response: they required no surgical excisions during 12 months of follow-up. That result applies to this subgroup and does not mean that all treated patients avoided surgery. The source report does not provide a comparison with a control group.
Treatment starts with surgery to remove visible papillomas, followed by four intramuscular doses given every three weeks. Voceryq is approved for use with the CELLECTRA 5PSP DNA medicine delivery device. Label warnings include muscle contractions, temporary bleeding and vasovagal reactions; commonly reported trial adverse events included injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness.
A Medical Option Alongside Repeat Surgery
RRP causes wart-like growths in the airways, often around the larynx, and those growths can return after removal. Repeated procedures can carry a risk of laryngeal injury, according to trial investigator Simon Best, making an approach intended to reduce surgery frequency relevant to patients who undergo operations repeatedly.
The approval does not establish that surgery can be replaced for everyone: the studied regimen itself begins with surgical removal of visible growths, and the trial’s complete-response result was limited to a subgroup. Its practical effect will depend on how well follow-up research confirms benefit and on how patients respond over time.
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RRP is caused by human papillomavirus, particularly HPV types 6 and 11. The growths can develop in the larynx and, in severe cases, spread through the respiratory tract and make breathing difficult. There is no cure described in the source report; surgery can remove papillomas, but they may recur.
Voceryq contains two plasmids with genetic coding for HPV proteins and interleukin 12. The treatment is intended to prompt a patient’s healthy cells to produce those proteins and stimulate immune responses against cells infected with the HPV types linked to RRP. The FDA had approved another RRP immunotherapy, zopapogene imadenovec (Papzimeos), in 2025, according to the report.
“The approval of Voceryq is an important step in improving the quality of life for RRP patients as every surgery carries the risk of laryngeal injury.”
— Simon Best, MD, Johns Hopkins University investigator, in a statement from Inovio Pharmaceuticals
Questions About Benefit and Long-Term Outcomes
The FDA’s accelerated approval is based on the early-stage RRP-001 trial, and postmarketing trials are required to verify and describe Voceryq’s clinical benefit. The source report does not give a deadline for those studies or details about their design.
The reported 27% complete-response rate covers 26 participants with at least three prior-year surgeries and a 12-month follow-up period. The available material does not establish how durable responses are beyond that period, how results compare with other treatment approaches, or which patients are most likely to benefit. It also does not provide a full account of outcomes for all 32 trial participants.
Postmarketing Studies Must Confirm Benefit
Inovio and the FDA will need to carry out the required postmarketing studies to further describe and verify the treatment’s clinical benefit. Until those results are available, the trial findings provide an initial measure of response rather than a complete picture of long-term effectiveness.
For patients and clinicians, the immediate questions include whether Voceryq can reduce the frequency of repeat excisions in routine care, how long any response lasts and how its risks compare with the burden of ongoing surgery. The approval announcement does not specify when the required studies will report results.
Key Questions
What is Voceryq approved to do?
The FDA approved Voceryq for adults with recurrent respiratory papillomatosis to reduce the frequency of surgical excisions of papillomas. The approval does not say that surgery will no longer be needed.
What did the trial find?
In the RRP-001 trial, 27% of 26 patients who had at least three surgeries in the prior 12 months had no surgical excisions during 12 months of follow-up. This subgroup result is not a response rate for every participant or every patient with RRP.
Does treatment begin without surgery?
No. The described regimen begins with surgical removal of visible papillomas, followed by four intramuscular doses of Voceryq at three-week intervals.
What side effects were reported?
Trial reports listed injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among common adverse events. The label also warns of muscle contractions, temporary bleeding and vasovagal reactions.
Is the treatment’s benefit fully established?
Not yet. The FDA granted accelerated approval based on early-stage trial data and requires postmarketing studies to verify and describe clinical benefit. The source report does not state when those studies are expected to finish.
Source: medpagetoday.com
