Clinical Scorecard: FDA approves HPV immunotherapy for recurrent respiratory papillomatosis

At a Glance

Key Highlights

• The FDA granted accelerated approval to Voceryq to reduce the frequency of surgical papilloma excisions in adults with RRP.
• The approval is the first US approval of a plasmid DNA-based immunotherapy.
• Evidence came from a multicenter, open-label, single-arm phase 1/2 study of 32 adults; the study had no concurrent control group.
• Among 26 patients who had required at least 3 surgeries before treatment, 7 had no surgical papilloma excisions during the following 12 months.
• Continued approval may depend on verification of clinical benefit in a confirmatory study.

Guideline-Based Recommendations

Diagnosis

• The source provides no diagnostic recommendations.

Management

Monitoring & Follow-up

Risks

Patient & Prescribing Data

Adults with recurrent respiratory papillomatosis. The supporting study enrolled 32 adults who had required at least 2 surgical interventions during the preceding 12 months.

The FDA prescribing information recommends 4 intramuscular doses of 6.25 mg, 3 weeks apart, after surgical removal of visible papillomas. In the study efficacy population of 26 patients with at least 3 prior-year surgeries, 7 required no excisions in the subsequent 12 months; the median number of pretreatment surgeries was 4.5.

Clinical Best Practices

• Remove visible papillomas surgically before starting treatment.
• Use the CELLECTRA 5PSP device and have a trained health care professional administer each dose.
• Observe injection sites for at least 30 minutes after each administration.
• Avoid administration at sites with the listed implants or skin abnormalities.

Related Resources & Content

• FDA press release
• FDA prescribing information
• INOVIO press release, October 30