palbociclib
Marketed as IBRANCE.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| NDA207103 | IBRANCE | 2015-02-03 | PFIZER |
Manufacturers
PFIZER
Common denial patterns
- Step therapy requiring endocrine monotherapy first
- Combination partner not formulary (specific AI denied)
- Continuation beyond progression denied
- Specialty pharmacy network restriction
Specific notes
Brand: Ibrance. CDK4/6 inhibitor for HR+/HER2- metastatic breast cancer. First-in-class. PALOMA trial series. Loss of exclusivity expected ~2027.
Pfizer Oncology Together: https://www.pfizeroncologytogether.com
Frequently asked questions
Why does insurance commonly deny palbociclib?
Step therapy requiring endocrine monotherapy first; Combination partner not formulary (specific AI denied); Continuation beyond progression denied; Specialty pharmacy network restriction.
When was palbociclib FDA approved?
Earliest FDA approval on record: 2015-02-03.
What brand names are sold as palbociclib?
IBRANCE.
Is there a patient assistance program for palbociclib?
Yes — Pfizer Oncology Together at https://www.pfizeroncologytogether.com.
What's specific to palbociclib?
Brand: Ibrance. CDK4/6 inhibitor for HR+/HER2- metastatic breast cancer. First-in-class. PALOMA trial series. Loss of exclusivity expected ~2027.
Related
Sources
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