Active Ingredient History
Palbociclib is an oral, reversible, selective, small-molecule inhibitor of CDK4 and CDK6 indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. CDK4 and CDK6 along with their regulatory partner cyclin D1 play a key role in regulating the G1- to S-phase cell-cycle transition via regulation of phosphorylation of the retinoblastoma (Rb) protein. Inhibition of these proteins leads to reduced phosphorylation of Rb, inhibition of downstream signalling, and increased tumor growth arrest. Palbociclib received an accelerated approval from the Food and Drug Administration on February 3, 2015. Palbociclib is marketed under the trade name Ibrance. IBRANCE is a kinase inhibitor indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Adenocarcinoma (Phase 2)
Adenocarcinoma of Lung (Early Phase 1)
Anemia (Phase 1)
Astrocytoma (Phase 2)
Bile Duct Neoplasms (Phase 2)
Biomarkers (Phase 3)
Brain Neoplasms (Phase 2)
BRCA1 Protein (Phase 1)
Breast Diseases (Phase 1/Phase 2)
Breast Neoplasms, Male (Phase 2)
Carcinoma (Phase 2)
Carcinoma, Ductal, Breast (Phase 1)
Carcinoma, Hepatocellular (Phase 2)
Carcinoma, Intraductal, Noninfiltrating (Phase 2)
Carcinoma, Non-Small-Cell Lung (Phase 2)
Carcinoma, Ovarian Epithelial (Phase 2)
Carcinoma, Renal Cell (Phase 1)
Carcinoma, Squamous Cell (Phase 2)
Carcinoma, Transitional Cell (Phase 2)
Chordoma (Phase 2)
Choroid Plexus Neoplasms (Phase 1)
Colonic Neoplasms (Phase 2)
Colorectal Neoplasms (Phase 2)
Cyclin D1 (Phase 2/Phase 3)
Cyclin D2 (Phase 2/Phase 3)
Cyclin D3 (Phase 2/Phase 3)
Diffuse Intrinsic Pontine Glioma (Phase 1)
Digestive System Neoplasms (Phase 1/Phase 2)
DNA Mismatch Repair (Phase 1)
Drugs, Investigational (Phase 3)
Drug Therapy, Combination (Phase 2)
Endometrial Neoplasms (Phase 2)
Ependymoma (Phase 2)
Epidermal Growth Factor (Phase 1)
ErbB Receptors (Phase 1)
Esophageal Neoplasms (Phase 2)
Fallopian Tube Neoplasms (Phase 1)
Gastrointestinal Neoplasms (Phase 2)
Gene Amplification (Phase 2/Phase 3)
Genes, erbB-2 (Phase 1)
Glioblastoma (Phase 2)
Glioma (Phase 2)
Gliosarcoma (Phase 2)
Hamartoma (Phase 1)
Head and Neck Neoplasms (Phase 1/Phase 2)
Healthy Volunteers (Phase 1)
Hepatoblastoma (Phase 2)
Histiocytosis, Langerhans-Cell (Phase 2)
Hodgkin Disease (Phase 1)
Hormones (Phase 2)
Intestinal Neoplasms (Phase 2)
Kidney Failure, Chronic (Phase 1)
Kidney Neoplasms (Phase 2)
Leukemia (Phase 1)
Leukemia, Lymphocytic, Chronic, B-Cell (Phase 1)
Leukemia, Lymphoid (Phase 1)
Leukemia, Myeloid, Acute (Phase 1/Phase 2)
Leukemia, Myeloid, Chronic-Phase (Phase 1)
Leukemia, Myelomonocytic, Chronic (Phase 1)
Leukemia, T-Cell (Phase 1)
Liposarcoma (Phase 2)
Liver Neoplasms (Phase 2)
Lung Neoplasms (Phase 2/Phase 3)
Lymphoma (Phase 2)
Lymphoma, B-Cell (Phase 2)
Lymphoma, Mantle-Cell (Phase 2)
Lymphoma, Non-Hodgkin (Phase 2)
Lymphoma, T-Cell (Phase 1)
Medulloblastoma (Phase 2)
Melanoma (Phase 2)
Meningioma (Phase 1)
Mesothelioma (Phase 1)
Multiple Myeloma (Phase 2)
Mutation (Phase 1/Phase 2)
Myelodysplastic Syndromes (Phase 1)
Myeloproliferative Disorders (Phase 1)
Nasopharyngeal Carcinoma (Phase 2)
Neoadjuvant Therapy (Phase 3)
Neoplasm Metastasis (Phase 2)
Neoplasms ()
Neoplasms, Germ Cell and Embryonal (Phase 2)
Neoplasms, Squamous Cell (Phase 1)
Neuroblastoma (Phase 2)
Neuroectodermal Tumors (Phase 2)
Oligodendroglioma (Phase 2)
Osteosarcoma (Phase 2)
Ovarian Neoplasms (Phase 2)
Pancreatic Neoplasms (Phase 2)
Papillomavirus Infections (Phase 1/Phase 2)
Precursor Cell Lymphoblastic Leukemia-Lymphoma (Phase 1/Phase 2)
Primary Myelofibrosis (Phase 1)
Prostatic Neoplasms (Phase 2)
Receptors, Estrogen (Phase 1)
Rhabdoid Tumor (Phase 2)
Rhabdomyosarcoma (Phase 2)
Sarcoma (Phase 3)
Sarcoma, Ewing (Phase 2)
Seminoma (Phase 2)
Skin Neoplasms (Phase 2)
Small Cell Lung Carcinoma (Phase 2)
Squamous Cell Carcinoma of Head and Neck (Phase 3)
Stomach Neoplasms (Phase 2)
Teratoma (Phase 2)
Testicular Neoplasms (Phase 2)
Thymus Neoplasms (Phase 2)
Thyroid Neoplasms (Phase 2)
Triple Negative Breast Neoplasms (Phase 2)
Urinary Bladder Neoplasms (Phase 2)
Uterine Cervical Neoplasms (Phase 2)
Wilms Tumor (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
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