Drug
pembrolizumab
Marketed as KEYTRUDA.
Generic name
pembrolizumab
Brand names
KEYTRUDA
First FDA approval
2014-09-04
Drug class
Immune checkpoint inhibitors
Patient assistance program
Merck Access Program
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA125514 | KEYTRUDA | 2014-09-04 | MERCK SHARP DOHME |
Manufacturers
MERCK SHARP DOHME
Common denial patterns
- Off-label indication denial
- Combination therapy denial
- Continuation beyond 2 years
Specific notes
Approved across 30+ cancer types. NCCN compendium often supports off-label uses.
Manufacturer patient assistance
Merck Access Program: https://www.merckaccessprogram-keytruda.com
Frequently asked questions
Why does insurance commonly deny pembrolizumab?
Off-label indication denial; Combination therapy denial; Continuation beyond 2 years.
When was pembrolizumab FDA approved?
Earliest FDA approval on record: 2014-09-04.
What brand names are sold as pembrolizumab?
KEYTRUDA.
Is there a patient assistance program for pembrolizumab?
Yes — Merck Access Program at https://www.merckaccessprogram-keytruda.com.
What's specific to pembrolizumab?
Approved across 30+ cancer types. NCCN compendium often supports off-label uses.
Related
Sources
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