Drug profile · INN
palbociclib
IBRANCE
palbociclib (IBRANCE) is a cyclin-dependent kinase 4/cyclin d1 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
Drug details — palbociclib
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- ORAL
- Patents
- 1
- Programs
- 26
- Data quality
- 0.84
Quick answer
palbociclib (IBRANCE) is a cyclin-dependent kinase 4/cyclin d1 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
Key facts
Mechanism of action
Cyclin-dependent kinase 4/cyclin D1 inhibitor
Primary target: CDK6/cyclin D1
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
| NMPA | clinical trials | — |
Recent coverage
FDA Approves Companion Diagnostic for Inavolisib in HR+/HER2–, PIK3CA-Mutated Breast Cancer
The FDA has approved FoundationOne CDx as a companion diagnostic for inavolisib (Itovebi) in combination with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. This approval expands the targeted therapy landscape and underscores the importance of genomic testing in patient selection.
Ibrance Heirs and Gilead's Tubulis Data at ASCO26
This article delves into the latest developments from ASCO26, focusing on Ibrance heirs and Gilead's Tubulis data. Discover the implications for pharmaceutical stakeholders.
Pipeline programs
Related & competitor drugs
Related patents
Frequently asked questions
What is palbociclib?
palbociclib (IBRANCE) is a cyclin-dependent kinase 4/cyclin d1 inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.
What is the brand name for palbociclib?
IBRANCE is a marketed brand name for palbociclib. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of palbociclib?
palbociclib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.