Otolaryngology
Recurrent respiratory papillomatosis: Voceryq, for prescribers
Voceryq on what its first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for recurrent respiratory papillomatosis. One other FDA-approved medicine for recurrent respiratory papillomatosis has no prescribing guide here yet and is listed below.
The recurrent respiratory papillomatosis prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drug with a prescribing guide
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Voceryqdoruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd | |
|---|---|
| Label dated | October 30, 2026 |
| Starting dose | Debulk visible papilloma to minimal residual disease; the label gives no interval. |
| Dispensing gate | No REMS, boxed warning or contraindications; surgical debulking of visible papilloma before dose 1; a CELLECTRA 5PSP device, requested from INOVIO at 1-855-INOVIO1, and a provider trained in its use; current height and weight for needle depth; a deltoid or anterolateral quadriceps site clear of an ipsilateral ICD or pacemaker, metal implants and skin abnormalities |
| Required monitoring | At least 30 minutes of observation after each dose for injection-site reactions; electroporation effects including vasovagal reactions and transient CPK changes; no laboratory monitoring specified; efficacy in the label judged by surgical need over 12 months |
| Example PA threshold | No public payer policy found as of November 9, 2026; label indication is adults with RRP, with no surgery-count or prior-therapy criterion; RRP-001 enrolled 2 or more surgeries in the prior 12 months, and the efficacy population had 3 or more |
| Support line | No INOVIO patient support program published as of November 9, 2026; 1-855-INOVIO1 for a representative, adverse reaction reports and the CELLECTRA 5PSP; ordering expected about 60 days after the October 30, 2026 approval, full launch in the first quarter of 2027 |
- Label dated
- October 30, 2026
- Starting dose
- Debulk visible papilloma to minimal residual disease; the label gives no interval.
- Dispensing gate
- No REMS, boxed warning or contraindications; surgical debulking of visible papilloma before dose 1; a CELLECTRA 5PSP device, requested from INOVIO at 1-855-INOVIO1, and a provider trained in its use; current height and weight for needle depth; a deltoid or anterolateral quadriceps site clear of an ipsilateral ICD or pacemaker, metal implants and skin abnormalities
- Required monitoring
- At least 30 minutes of observation after each dose for injection-site reactions; electroporation effects including vasovagal reactions and transient CPK changes; no laboratory monitoring specified; efficacy in the label judged by surgical need over 12 months
- Example PA threshold
- No public payer policy found as of November 9, 2026; label indication is adults with RRP, with no surgery-count or prior-therapy criterion; RRP-001 enrolled 2 or more surgeries in the prior 12 months, and the efficacy population had 3 or more
- Support line
- No INOVIO patient support program published as of November 9, 2026; 1-855-INOVIO1 for a representative, adverse reaction reports and the CELLECTRA 5PSP; ordering expected about 60 days after the October 30, 2026 approval, full launch in the first quarter of 2027
Other FDA-approved medicines for recurrent respiratory papillomatosis
These have no Trial Friend prescribing guide yet, so they are not in the comparison above. Some are approved for a different form or use of the condition than the guides above, and each drug page gives its indication. The list comes from Trial Friend's audited list of FDA labels that name this condition, built October 21, 2026.
- PapzimeosZopapogene imadenovecPrecigen
FDA decisions for recurrent respiratory papillomatosis
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
No pending or recent decisions on the calendar.
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- November 2026Voceryq. DailyMed, the usual home of FDA labels, did not list Voceryq on November 9, 2026. This page was read from the package insert on the FDA's Voceryq product page instead. FDA product page
- October 2026Voceryq. The FDA said this was the first approval of a plasmid DNA-based immunotherapy in the US. Voceryq also holds Breakthrough Therapy and Orphan Drug designations from the FDA. FDA announcement
- October 2026Voceryq. The FDA granted accelerated approval on October 30, 2026, for adults with recurrent respiratory papillomatosis. The letter requires a study of at least 50 adults and children, with a final report due August 30, 2032. FDA letter
- October 2026Voceryq. The package insert on the FDA product page is marked Revised 10/2026. As the first Voceryq label, it has no recent major changes section and no boxed warning. FDA label
Open trials
Questions prescribers ask about Recurrent respiratory papillomatosis
Does Voceryq require a REMS?
No. Voceryq has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Voceryq require?
At least 30 minutes of observation after each dose for injection-site reactions; electroporation effects including vasovagal reactions and transient CPK changes; no laboratory monitoring specified; efficacy in the label judged by surgical need over 12 months.
What do insurers require before covering Voceryq?
This is one public insurer policy, an example rather than every plan. No public payer policy found as of November 9, 2026; label indication is adults with RRP, with no surgery-count or prior-therapy criterion; RRP-001 enrolled 2 or more surgeries in the prior 12 months, and the efficacy population had 3 or more.
Which support program starts Voceryq patients on therapy?
No INOVIO patient support program published as of November 9, 2026; 1-855-INOVIO1 for a representative, adverse reaction reports and the CELLECTRA 5PSP; ordering expected about 60 days after the October 30, 2026 approval, full launch in the first quarter of 2027.
A reference for licensed professionals, checked on November 9, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Recurrent respiratory papillomatosis page and the first 90 days pages for Voceryq.