nivolumab
Marketed as OPDIVO.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA125554 | OPDIVO | 2014-12-22 | BRISTOL MYERS SQUIBB |
Manufacturers
BRISTOL MYERS SQUIBB
Common denial patterns
- Off-label indication denial despite NCCN compendium support
- Combination with ipilimumab denied as duplicate therapy
- Adjuvant use denial citing 'no overall survival data'
- Continuation beyond 2 years
Specific notes
Brand: Opdivo. PD-1 inhibitor approved across 20+ indications. Opdualag (nivolumab + relatlimab) is the first LAG-3 combination. Subcutaneous nivolumab (Opdivo Qvantig) FDA-approved December 2024 — appeal denials of subQ formulation citing IV-only preference.
BMS Access Support: https://www.bmsaccesssupport.com
Frequently asked questions
Why does insurance commonly deny nivolumab?
Off-label indication denial despite NCCN compendium support; Combination with ipilimumab denied as duplicate therapy; Adjuvant use denial citing 'no overall survival data'; Continuation beyond 2 years.
When was nivolumab FDA approved?
Earliest FDA approval on record: 2014-12-22.
What brand names are sold as nivolumab?
OPDIVO.
Is there a patient assistance program for nivolumab?
Yes — BMS Access Support at https://www.bmsaccesssupport.com.
What's specific to nivolumab?
Brand: Opdivo. PD-1 inhibitor approved across 20+ indications. Opdualag (nivolumab + relatlimab) is the first LAG-3 combination. Subcutaneous nivolumab (Opdivo Qvantig) FDA-approved December 2024 — appeal denials of subQ formulation citing IV-only preference.
Related
Sources
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