Ibrance

Product manufactured by U.s. Pharmaceuticals

Application Nr Approved Date Route Status External Links
NDA207103 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ibrance Is Indicated For The Treatment Of Hr-Positive, Her2-Negative Advanced Or Metastatic Breast Cancer In Combination With: Letrozole As Initial Endocrine Based Therapy In Postmenopausal Women, Or Fulvestrant In Women With Disease Progression Following Endocrine Therapy. The Indication In Combination With Letrozole Is Approved Under Accelerated Approval Based On Progression-Free Survival (Pfs) [See Clinical Studies (14) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. Ibrance Is A Kinase Inhibitor Indicated For The Treatment Of Hormone Receptor (Hr)-Positive, Human Epidermal Growth Factor Receptor 2 (Her2)-Negative Advanced Or Metastatic Breast Cancer In Combination With: Letrozole As Initial Endocrine Based Therapy In Postmenopausal Women ( 1 ), Or Fulvestrant In Women With Disease Progression Following Endocrine Therapy. The Indication In Combination With Letrozole Is Approved Under Accelerated Approval Based On Progression-Free Survival (Pfs). Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Palbociclib PALBOCICLIB ZINC3938686

Comments