Cellectra 5PSP delivery device. Illustration from Inovio’s Voceryq prescribing information, via FDA.
The FDA has asked Inovio Pharmaceuticals, a company developing DNA-based medicines, to reanalyze its human factors testing of the Cellectra 5PSP, the electroporation device that delivers its newly approved drug Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd), a pioneering plasmid DNA-based immunotherapy. The agency is also asking it to verify the device’s sharps injury prevention feature.
The FDA granted Voceryq accelerated approval on Oct. 30, making it the first plasmid DNA immunotherapy for adults with recurrent respiratory papillomatosis (RRP).
Cellectra 5PSP delivers the injection and electrical pulses that help the DNA enter cells. The FDA approved Voceryq with agreed postmarketing work to reassess the device’s usability data and test its protection against sharps injuries. Inovio said on Oct. 30 that it expected orders and shipments to begin in about 60 days, with a full commercial launch in the first quarter of 2027.
Recurrent respiratory papillomatosis (RRP) is a rare disease in which human papillomavirus (HPV) causes growths in the airway. Doctors usually treat it with repeated surgeries. HPV types 6 and 11, low-risk strains of the virus that rarely cause cancer, account for more than 90% of cases.
Voceryq treats the disease with a combination of two DNA plasmids, small circles of DNA that carry genetic instructions, and electroporation, brief electrical pulses that temporarily open muscle cells’ membranes. Inovio designed the treatment to train T cells to find and kill infected papilloma cells.
According to the Voceryq label, the device’s injection and electroporation delivery sequence takes about 10 seconds once triggered. After surgeons remove visible growths, patients receive a 1 mL dose every three weeks for a total of four doses. The label calls for at least 30 minutes of monitoring for local reactions after treatment.
Only healthcare providers trained on the device can administer Voceryq, and providers order the device from Inovio separately from the drug.
The device questions
Under two postmarketing commitments in the approval letter, Inovio agreed to reanalyze its human factors validation study to separate close calls from use difficulties, with root cause and clinical risk analysis. It also agreed to conduct verification and validation testing of the device’s sharps injury prevention feature.
The FDA’s human factors guidance, updated in August 2026, recommends observing representative users as they perform critical tasks. Testing records use errors, close calls in which a user recovers before potential harm occurs, and difficulties such as confusion or repeated attempts to complete a task. Investigators analyze the causes and associated risks to determine whether the design, labeling or training needs to change.
Under the commitments, Inovio will submit final reports by June 30, 2027, if the work supports keeping the device unchanged. If modifications are needed, the company will submit proposed changes and supplemental validation testing protocols by that date, then submit the results in a prior approval supplement by Dec. 30, 2027. That supplement seeks FDA approval for the changes.
In October 2016, the FDA placed the planned Phase 3 program for VGX-3100, another Inovio DNA immunotherapy, on hold while it sought shelf-life data for Cellectra 5PSP’s disposable parts. The trial had yet to enroll patients. The agency lifted that hold on June 6, 2017.
The evidence behind the approval
In an open-label, single-arm clinical trial of 32 adults, seven of the 26 patients in the FDA’s efficacy analysis (27%) needed no surgery for a year after treatment. Those 26 patients had undergone at least three surgeries in the preceding 12 months, including the procedure before the first dose. In a retrospective follow-up study published by the investigators, 14 of 28 participants needed no surgery in the second year. That follow-up drew from the full original trial population; four participants were lost to follow-up or had not consented. Both analyses used patients’ earlier surgical histories as the comparison.
The FDA based accelerated approval on reduced surgery frequency, an intermediate clinical endpoint reasonably likely to predict clinical benefit. A required confirmatory study will assess longer-term benefit, including durable elimination of surgery and symptomatic improvement. Inovio must submit its final report by Aug. 30, 2032. The FDA can withdraw approval if the study fails to verify benefit or the company fails to conduct it with due diligence.
Inovio did not respond to a request for comment at the time of publication.
Filed Under: Drug Delivery, Rare disease, Regulatory affairs
