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FDA grants accelerated approval to Voceryq, first plasmid DNA immunotherapy for recurrent respiratory papillomatosis

🇺🇸 FDA CBER · Fri 30 Oct 2026

CBER has cleared Inovio's Voceryq for adults with RRP on a surgery-frequency endpoint, with post-approval trials required to confirm clinical benefit.

The US Food and Drug Administration has granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for adults with recurrent respiratory papillomatosis (RRP). The agency says it is the first plasmid DNA-based immunotherapy approved in the US. The approval went to Inovio Pharmaceuticals, Inc. and carries Breakthrough and Orphan Drug designations.

RRP is a rare, chronic condition in which HPV types 6 and/or 11 cause wart-like growths, called papillomas, in the airways, most often around the larynx. Symptoms include hoarseness, chronic cough and voice changes, and severe cases can cause breathing difficulty. Surgery removes the growths but is not curative, as the virus persists in tissue, so patients often need repeated procedures over many years.

Voceryq delivers two plasmids into cells: one encoding specific HPV proteins and the other encoding the immune-enhancing molecule IL-12. It is given by intramuscular injection with the CELLECTRA 5PSP Device, which uses electroporation, brief electrical pulses that temporarily open cell membranes, to aid delivery.

The approval rests on an open-label, multicentre trial in 32 adults who had undergone two or more surgeries in the prior 12 months. FDA cited a reduced frequency of surgical procedures as an intermediate clinical endpoint reasonably likely to predict clinical benefit. Of 26 patients with at least three baseline surgeries, seven (27%) needed no surgical intervention in the first year after treatment.

The most common adverse reactions were injection site reactions, headache, fatigue, hypertension, nausea and dizziness. FDA also listed effects linked to electroporation, including brief muscle contractions or tetany, temporary bleeding at the injection site, anxiety, vasovagal reactions, transient changes in creatine phosphokinase, redness and pain at the injection site. The manufacturer must run post-approval clinical trials to verify and describe clinical benefit.

What it means for your team

  • Accelerated approval means confirmatory trials are mandatory; regulatory teams should track the commitments and timelines that follow.
  • PV teams should note the combined safety profile of the product and the electroporation device, including vasovagal reactions, tetany and CPK changes.
  • Quality and device teams should recognise that the drug and the CELLECTRA 5PSP Device are used together, which affects administration and training considerations.
  • Market-access teams should note that the evidence is a single-arm, open-label dataset of 32 patients using a surrogate-type endpoint, which payers may scrutinise.

Official source: FDA CBER ↗

Article written by VigiEye from the official source (FDA CBER). AI-assisted; check the source before acting.

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