Palbociclib 125mg: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Palbociclib 125mg appears in the FDA drug-label database. Marketed as Ibrance.

Drug class

Kinase Inhibitor (FDA established pharmacologic class)

Mechanism of action

Kinase Inhibitors; Cytochrome P450 3A Inhibitors (as stated on the FDA label)

FDA-approved use

IBRANCE is a kinase inhibitor indicated: • for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy ( 1.1 ); or o fulvestrant in patients with disease progression following endocrine therapy. ( 1.1 ) • in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test, following recurrence on or after completing adjuvant endocrine therapy. ( 1.1 ) • in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2‑positive locally advanced or metastatic breast cancer following induction treatment. ( 1.2 ) 1.1 HER2-Negative Metastatic Breast Cancer IBRANCE is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combi…

FDA label via openFDA