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FDA grants accelerated approval to an immunotherapy for adults with recurrent respiratory papillomatosis, with benefit still to be confirmed

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The FDA granted accelerated approval October 30 to Voceryq for adults with recurrent respiratory papillomatosis, a rare airway disease that can require repeated surgery. The agency cited fewer surgical procedures in a small, open-label trial. The manufacturer must run post-approval trials to verify the clinical benefit; the approval announcement does not establish that the treatment cures the disease.

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The Food and Drug Administration granted accelerated approval October 30 to Voceryq for adults with recurrent respiratory papillomatosis. The rare disease causes growths in the airways and can require repeated operations; FDA says the new treatment reduced the frequency of surgeries in a clinical trial.

What the approval covers

The approval is for adults with recurrent respiratory papillomatosis, or RRP. FDA describes it as a chronic disease caused by human papillomavirus types 6 and/or 11. Growths often form around the voice box and can cause hoarseness, cough and voice changes. In severe cases, they can make breathing difficult.

Surgery can remove the growths, but FDA says the virus persists in tissue and patients may need procedures over many years. The agency says there is no cure. Voceryq is a plasmid DNA-based immunotherapy designed to prompt an immune response to cells infected with the HPV types that cause RRP. It is given by injection using a device that applies brief electrical pulses to help deliver the treatment into cells.

What the trial showed

FDA evaluated safety and effectiveness in an open-label trial of 32 adults. Eligible participants had two or more surgeries to remove airway growths in the year before treatment, including a surgery scheduled at trial entry. Among 26 participants who had at least three baseline surgeries, seven did not require surgery during the first year after treatment, according to the announcement.

That is the reported result for a subgroup, not a result for every person in the trial. The release does not report a controlled comparison. FDA based accelerated approval on reduced surgical frequency as an intermediate clinical endpoint reasonably likely to predict benefit. The manufacturer, Inovio Pharmaceuticals, must conduct post-approval trials to verify and describe clinical benefit.

FDA lists injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among the most commonly reported adverse reactions. It also identifies potential adverse effects associated with the electrical-pulse delivery technique. The agency's announcement gives no treatment price or availability timetable.

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