Active Ingredient History
Pexidartinib (PLX3397) is a small-molecule receptor tyrosine kinase (RTK) inhibitor with potential antineoplastic activity. Pexidartinib binds to and inhibits phosphorylation of stem cell factor receptor (KIT), colony-stimulating factor-1 receptor (CSF1R) and FMS-like tyrosine kinase 3 (FLT3), which may result in the inhibition of tumor cell proliferation and down-modulation of macrophages, osteoclasts and mast cells involved in the osteolytic metastatic disease. FDA has granted Breakthrough Therapy Designation to pexidartinib (PLX3397) for the treatment of tenosynovial giant cell tumor (TGCT) where surgical removal of the tumor would be associated with potentially worsening functional limitation or severe morbidity. In addition to Breakthrough Therapy Designation, pexidartinib (PLX3397) has been granted Orphan Drug Designation by FDA for the treatment of pigmented villonodular synovitis (PVNS) and giant cell tumor of the tendon sheath (GCT-TS). It also has received Orphan Designation from the European Commission for the treatment of TGCT. 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 |
|---|
Carcinoma, Giant Cell (approved 2019)
Arthritis, Rheumatoid (Phase 1)
Breast Neoplasms (Phase 2)
Carcinoma, Giant Cell (Phase 3)
Carcinoma, Non-Small-Cell Lung (Phase 1/Phase 2)
Colorectal Neoplasms (Phase 1)
Drug Interactions (Phase 1)
Gastrointestinal Stromal Tumors (Phase 1/Phase 2)
Giant Cell Tumor of Tendon Sheath (Phase 4)
Giant Cell Tumors (Phase 3)
Glioblastoma (Phase 2)
Healthy Volunteers (Phase 1)
Hemangiosarcoma (Phase 2)
Hodgkin Disease (Phase 2)
Intestinal Neoplasms (Phase 1/Phase 2)
Leukemia, Myeloid, Acute (Phase 1/Phase 2)
Leukemia, Promyelocytic, Acute (Phase 1/Phase 2)
Liver Diseases (Early Phase 1)
Melanoma (Phase 2)
Neoplasms (Phase 2)
Neurofibroma, Plexiform (Phase 1/Phase 2)
Neurofibrosarcoma (Phase 1/Phase 2)
Ovarian Neoplasms (Phase 1/Phase 2)
Pancreatic Neoplasms (Phase 1)
Precursor Cell Lymphoblastic Leukemia-Lymphoma (Phase 1/Phase 2)
Prostatic Neoplasms (Phase 2)
Sarcoma (Phase 1/Phase 2)
Squamous Cell Carcinoma of Head and Neck (Phase 1/Phase 2)
Synovitis, Pigmented Villonodular (Phase 3)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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