FDA approves INOVIO immunotherapy for rare disease after 78% reduction in surgeries
Key Facts
On October 30, 2026, the U.S. Food and Drug Administration granted accelerated approval to «Fuceric» for adults with recurrent respiratory papillomatosis, making it the first plasmid DNA-based immunotherapy approved by the agency in the United States. The treatment is marketed as «Fuceric» and was previously known as INO-3107; the approval is INOVIO’s first approved product. The decision was based on a reduction in the need for surgery, a measure the agency considers likely to predict clinical benefit. Company data showed a 78% reduction in the mean annual number of surgeries in the second year after treatment compared with the year before treatment. The director of the FDA’s Center for Biologics Evaluation and Research said patients face “an exhausting and unrelenting cycle of repeated procedures.”
Recurrent respiratory papillomatosis is a rare, chronic disease caused by human papillomavirus types 6 and 11. Growths can develop in the airway, causing hoarseness, a chronic cough or voice changes, and may lead to difficulty breathing if they spread. There is no cure for the disease, as the virus remains in the tissues even after the growths are surgically removed. Patients may therefore need repeated procedures over many years. An FDA official said patients often face “an exhausting and unrelenting cycle of repeated procedures,” describing the burden of repeated treatment for this group.
«Fuceric» is a recombinant plasmid DNA-based immunotherapy that delivers two plasmids to the body’s cells. It is administered by intramuscular injection using the «CELLECTRA 5PSP» device, which uses electrical pulses to facilitate delivery of the dose into cells. The FDA evaluated its safety and efficacy in an open-label, multicenter trial involving 32 adults. The trial required each participant to have undergone two or more surgeries in the preceding 12 months, including a scheduled surgery upon entering the study. This design measures outcomes in patients who had previously required repeated surgical interventions.
In the result cited by the agency in announcing the approval, 7 of 26 patients, or 27%, who had at least three baseline surgeries required no surgical intervention during the first year after treatment. INOVIO reported that 81% of participants, or 26 of 32, reduced their number of surgeries by at least one in the first year. By the end of the second year, the reduction was still in place for 91% of evaluable patients, or 21 of 23. The company also said that 28%, or 9 of 32, needed no surgery in the first year, rising to 50%, or 14 of 28, in the second year. These figures show varying outcomes by group, time period and outcome measure, including the need for surgery and a reduction in the number of procedures.
The company said the mean annual number of surgeries was 4.1 in the year before treatment among 32 participants, compared with 0.9 in the second year after treatment among 28 participants, equivalent to a reduction of 78%. The accelerated approval is based on reducing the frequency of surgery as an intermediate clinical measure that the FDA considers likely to predict clinical benefit. INOVIO must conduct post-approval clinical trials to verify and describe the treatment’s benefit. The agency listed injection-site reactions, headache, fatigue, high blood pressure, nausea and dizziness among the most commonly reported adverse reactions. The company had requested priority review, which it said typically takes 6 months, but the application received a standard 10-month review, with an October 30, 2026 target decision date.
Patients with the disease had another approved treatment: in August 2025, the FDA approved «Papzimeos» for adults with recurrent respiratory papillomatosis, for use as an adjunctive treatment after surgical removal of growths. INOVIO reported in June 2026 that cash and cash equivalents and short-term investments totaled $36.7 million on June 30, and that it received net proceeds of $18.3 million from a public offering in July. The company said its financial resources are expected to fund operations through late in the first quarter of 2027, including a potential launch of the treatment. It added that it had identified or contracted with U.S. commercial partners, including a specialty distributor and pharmacy, a logistics services provider and a patient services center. The company also noted that it needs additional funding to continue research and development, warning that insufficient funds could delay, reduce or suspend clinical or preclinical programs.