Active Ingredient History
Osimertinib is an oral, third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) drug developed by AstraZeneca Pharmaceuticals. Its use is indicated for the treatment of metastatic non-small cell lung cancer (NSCLC) in cases where tumour EGFR expression is positive for the T790M mutation as detected by FDA-approved testing and which has progressed following therapy with a first-generation EGFR tyrosine kinase inhibitor. Approximately 10% of patients with NSCLC have a rapid and clinically effective response to EGFR-TKIs due to the presence of specific activating EGFR mutations within the tumour cells. More specifically, deletions around the LREA motif in exon 19 and exon 21 L858R point mutations are correlated with response to therapy. Osimertinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that binds to certain mutant forms of EGFR (T790M, L858R, and exon 19 deletion) that predominate in non-small cell lung cancer (NSCLC) tumours following treatment with first-line EGFR-TKIs. As a third-generation tyrosine kinase inhibitor, osimertinib is specific for the gate-keeper T790M mutation which increases ATP binding activity to EGFR and results in poor prognosis for late-stage disease. Furthermore, osimertinib has been shown to spare wild-type EGFR during therapy, thereby reducing non-specific binding and limiting toxicity. Osimertinib is marketed under the brand name Tagrisso. 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 (Phase 2)
Antineoplastic Agents (Phase 1/Phase 2)
Bile Duct Neoplasms (Phase 2)
Brain Neoplasms (Phase 3)
Breast Neoplasms (Phase 2)
Bronchial Neoplasms (Phase 1/Phase 2)
Carcinoma (Phase 3)
Carcinoma, Bronchogenic (Phase 1/Phase 2)
Carcinoma, Squamous Cell (Phase 2)
Cognition Disorders (Phase 2)
Colonic Neoplasms (Phase 2)
Colorectal Neoplasms (Phase 2)
Disease Progression (Phase 2)
Drugs, Investigational (Phase 3)
Drug Therapy (Phase 2)
Endometrial Neoplasms (Phase 2)
Epidermal Growth Factor (Phase 2)
Esophageal Neoplasms (Phase 2)
Genes, erbB-1 (Phase 1/Phase 2)
Glioblastoma (Phase 2)
Glioma (Phase 2)
Head and Neck Neoplasms (Phase 1)
Healthy Volunteers (Phase 1)
Immune Checkpoint Inhibitors (Phase 2)
Kidney Neoplasms (Phase 2)
Liver Neoplasms (Phase 2)
Lung Diseases (Phase 1/Phase 2)
Lung Neoplasms (Phase 3)
Lymphoma (Phase 2)
Melanoma (Phase 2)
Multiple Myeloma (Phase 2)
Mutation (Phase 3)
Neoplasm Metastasis (Phase 2)
Neoplasms ()
Neoplasms by Histologic Type (Phase 1/Phase 2)
Neoplasms by Site (Phase 1/Phase 2)
Neoplasms, Nerve Tissue (Phase 1/Phase 2)
Ovarian Neoplasms (Phase 2)
Pancreatic Neoplasms (Phase 2)
Progression-Free Survival (Phase 2/Phase 3)
Prostatic Neoplasms (Phase 2)
Protein Kinase Inhibitors (Phase 1/Phase 2)
Respiratory Tract Diseases (Phase 1/Phase 2)
Respiratory Tract Neoplasms (Phase 1/Phase 2)
Skin Neoplasms (Phase 2)
Small Cell Lung Carcinoma (Phase 3)
Squamous Cell Carcinoma of Head and Neck (Phase 2)
Stomach Neoplasms (Phase 2)
Thoracic Neoplasms (Phase 1/Phase 2)
Thyroid Neoplasms (Phase 2)
Tumor Suppressor Protein p53 (Phase 2)
Urinary Bladder Neoplasms (Phase 2)
Uterine Cervical Neoplasms (Phase 2)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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