Details
Stereochemistry | ACHIRAL |
Molecular Formula | C28H33N7O2.CH4O3S |
Molecular Weight | 595.713 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
CS(O)(=O)=O.COC1=C(NC2=NC=CC(=N2)C3=CN(C)C4=CC=CC=C34)C=C(NC(=O)C=C)C(=C1)N(C)CCN(C)C
InChI
InChIKey=FUKSNUHSJBTCFJ-UHFFFAOYSA-N
InChI=1S/C28H33N7O2.CH4O3S/c1-7-27(36)30-22-16-23(26(37-6)17-25(22)34(4)15-14-33(2)3)32-28-29-13-12-21(31-28)20-18-35(5)24-11-9-8-10-19(20)24;1-5(2,3)4/h7-13,16-18H,1,14-15H2,2-6H3,(H,30,36)(H,29,31,32);1H3,(H,2,3,4)
DescriptionCurator's Comment: Description was created based on several sources, including
https://www.drugbank.ca/drugs/DB09330
Curator's Comment: Description was created based on several sources, including
https://www.drugbank.ca/drugs/DB09330
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.
Originator
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: CHEMBL2363049 |
12.0 nM [IC50] |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | TAGRISSO Approved UseTAGRISSO is a kinase inhibitor indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC), as detected by an FDA approved
test, who have progressed on or after EGFR TKI therapy. Launch Date2015 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
660.7 nM |
80 mg 1 times / day steady-state, oral dose: 80 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
OSIMERTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
118 nM EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/29683562 |
80 mg single, oral dose: 80 mg route of administration: Oral experiment type: SINGLE co-administered: |
OSIMERTINIB plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
12670 nM × h |
80 mg 1 times / day steady-state, oral dose: 80 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
OSIMERTINIB plasma | Homo sapiens population: UNHEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
6770 nM × h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/29683562 |
80 mg single, oral dose: 80 mg route of administration: Oral experiment type: SINGLE co-administered: |
OSIMERTINIB plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
59.7 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/29683562 |
80 mg single, oral dose: 80 mg route of administration: Oral experiment type: SINGLE co-administered: |
OSIMERTINIB plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
5% |
OSIMERTINIB plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Disc. AE: Electrocardiogram QT prolonged, Neutropenia... Other AEs: Diarrhea, Diarrhea... AEs leading to discontinuation/dose reduction: Electrocardiogram QT prolonged (2.2%) Other AEs:Neutropenia (1.9%) Pneumonitis (grade 5, 1%) Pneumonia (grade 5, 4 patients) Cerebral hemorrhage (grade 5, 2 patients) Diarrhea (grade 1-2, 41%) Sources: Diarrhea (grade 3-4, 1%) Nausea (grade 1-2, 16.5%) Nausea (grade 3-4, 0.5%) Decreased appetite (grade 1-2, 15.3%) Decreased appetite (grade 3-4, 0.7%) Constipation (grade 1-2, 14.8%) Constipation (grade 3-4, 0.2%) Stomatitis (grade 1-2, 12%) Rash (grade 1-2, 40.5%) Generalized rash (grade 1-2, 40.5%) Rash erythematous (grade 1-2, 40.5%) Rash macular (grade 1-2, 40.5%) Rash maculo-papular (grade 1-2, 40.5%) Rash papular (grade 1-2, 40.5%) Rash pustular (grade 1-2, 40.5%) Erythema (grade 1-2, 40.5%) Folliculitis (grade 1-2, 40.5%) Acne (grade 1-2, 40.5%) Dermatitis (grade 1-2, 40.5%) Acneiform dermatitis (grade 1-2, 40.5%) Rash (grade 3-4, 0.5%) Generalized rash (grade 3-4, 0.5%) Rash erythematous (grade 3-4, 0.5%) Rash macular (grade 3-4, 0.5%) Rash maculo-papular (grade 3-4, 0.5%) Rash papular (grade 3-4, 0.5%) Rash pustular (grade 3-4, 0.5%) Erythema (grade 3-4, 0.5%) Folliculitis (grade 3-4, 0.5%) Acne (grade 3-4, 0.5%) Dermatitis (grade 3-4, 0.5%) Acneiform dermatitis (grade 3-4, 0.5%) Dry skin (grade 1-2, 31%) Eczema (grade 1-2, 31%) Skin fissures (grade 1-2, 31%) Xerosis (grade 1-2, 31%) Disorder nail (grade 1-2, 25%) Nail bed disorder (grade 1-2, 25%) Nail bed inflammation (grade 1-2, 25%) Nail bed tenderness (grade 1-2, 25%) Nail discoloration (grade 1-2, 25%) Nail dystrophy (grade 1-2, 25%) Nail infection (grade 1-2, 25%) Nail ridging (grade 1-2, 25%) Onychoclasis (grade 1-2, 25%) Onycholysis (grade 1-2, 25%) Onychomadesis (grade 1-2, 25%) Paronychia (grade 1-2, 25%) Pruritus (grade 1-2, 14%) Cough (grade 1-2, 13.8%) Cough (grade 3-4, 0.2%) Fatigue (grade 1-2, 13.5%) Fatigue (grade 3-4, 0.5%) Back pain (grade 1-2, 12.3%) Back pain (grade 3-4, 0.7%) Headache (grade 1-2, 9.8%) Headache (grade 3-4, 0.2%) Pneumonia (grade 1-2, 1.8%) Pneumonia (grade 3-4, 2.2%) Deep vein thrombosis (grade 1-2, 4.6%) Jugular vein thrombosis (grade 1-2, 4.6%) Pulmonary embolism (grade 1-2, 4.6%) Deep vein thrombosis (grade 3-4, 2.4%) Jugular vein thrombosis (grade 3-4, 2.4%) Pulmonary embolism (grade 3-4, 2.4%) Cerebrovascular accident (2.7%) Hyponatremia (grade 1-2, 22.6%) Hyponatremia (grade 3-4, 3.4%) Hypermagnesemia (grade 1-2, 19.3%) Hypermagnesemia (grade 3-4, 0.7%) Lymphopenia (grade 1-2, 59.7%) Lymphopenia (grade 3-4, 3.3%) Thrombocytopenia (grade 1-2, 52.8%) Thrombocytopenia (grade 3-4, 1.2%) Anemia (grade 1-2, 43.8%) Anemia (grade 3-4, 0.2%) Neutropenia (grade 1-2, 29.6%) Neutropenia (grade 3-4, 3.4%) |
240 mg 1 times / day multiple, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: multiple Dose: 240 mg, 1 times / day Sources: |
unhealthy, 71 years n = 1 Health Status: unhealthy Condition: EGFR L858R–mutant metastatic lung adenocarcinoma Age Group: 71 years Sex: F Population Size: 1 Sources: |
Other AEs: Nausea, Vomiting... |
240 mg 1 times / day steady, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: steady Dose: 240 mg, 1 times / day Sources: Page: 53 |
unhealthy n = 13 Health Status: unhealthy Condition: NSCLC Sex: M+F Population Size: 13 Sources: Page: 53 |
Other AEs: Rash, Diarrhea... Other AEs: Rash (60%) Sources: Page: 53Diarrhea (58%) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Neutropenia | 1.9% Disc. AE |
80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Electrocardiogram QT prolonged | 2.2% Disc. AE |
80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Cerebrovascular accident | 2.7% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pneumonia | grade 1-2, 1.8% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Stomatitis | grade 1-2, 12% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Back pain | grade 1-2, 12.3% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Fatigue | grade 1-2, 13.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Cough | grade 1-2, 13.8% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pruritus | grade 1-2, 14% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Constipation | grade 1-2, 14.8% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Decreased appetite | grade 1-2, 15.3% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nausea | grade 1-2, 16.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Hypermagnesemia | grade 1-2, 19.3% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Hyponatremia | grade 1-2, 22.6% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Disorder nail | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail bed disorder | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail bed inflammation | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail bed tenderness | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail discoloration | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail dystrophy | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail infection | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nail ridging | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Onychoclasis | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Onycholysis | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Onychomadesis | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Paronychia | grade 1-2, 25% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Neutropenia | grade 1-2, 29.6% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Dry skin | grade 1-2, 31% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Eczema | grade 1-2, 31% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Skin fissures | grade 1-2, 31% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Xerosis | grade 1-2, 31% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Deep vein thrombosis | grade 1-2, 4.6% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Jugular vein thrombosis | grade 1-2, 4.6% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pulmonary embolism | grade 1-2, 4.6% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Acne | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Acneiform dermatitis | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Dermatitis | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Erythema | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Folliculitis | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Generalized rash | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash erythematous | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash macular | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash maculo-papular | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash papular | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash pustular | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash | grade 1-2, 40.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Diarrhea | grade 1-2, 41% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Anemia | grade 1-2, 43.8% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Thrombocytopenia | grade 1-2, 52.8% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Lymphopenia | grade 1-2, 59.7% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Headache | grade 1-2, 9.8% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Anemia | grade 3-4, 0.2% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Constipation | grade 3-4, 0.2% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Cough | grade 3-4, 0.2% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Headache | grade 3-4, 0.2% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Acne | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Acneiform dermatitis | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Dermatitis | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Erythema | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Fatigue | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Folliculitis | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Generalized rash | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Nausea | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash erythematous | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash macular | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash maculo-papular | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash papular | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash pustular | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Rash | grade 3-4, 0.5% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Back pain | grade 3-4, 0.7% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Decreased appetite | grade 3-4, 0.7% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Hypermagnesemia | grade 3-4, 0.7% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Diarrhea | grade 3-4, 1% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Thrombocytopenia | grade 3-4, 1.2% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pneumonia | grade 3-4, 2.2% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Deep vein thrombosis | grade 3-4, 2.4% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Jugular vein thrombosis | grade 3-4, 2.4% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pulmonary embolism | grade 3-4, 2.4% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Lymphopenia | grade 3-4, 3.3% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Hyponatremia | grade 3-4, 3.4% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Neutropenia | grade 3-4, 3.4% | 80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pneumonitis | grade 5, 1% Disc. AE |
80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Cerebral hemorrhage | grade 5, 2 patients Disc. AE |
80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Pneumonia | grade 5, 4 patients Disc. AE |
80 mg 1 times / day steady, oral Recommended Dose: 80 mg, 1 times / day Route: oral Route: steady Dose: 80 mg, 1 times / day Sources: |
unhealthy, 63 years n = 411 Health Status: unhealthy Condition: EGFR T790M mutation-positive non-small cell lung cancer Age Group: 63 years Sex: M+F Population Size: 411 Sources: |
Diarrhea | 240 mg 1 times / day multiple, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: multiple Dose: 240 mg, 1 times / day Sources: |
unhealthy, 71 years n = 1 Health Status: unhealthy Condition: EGFR L858R–mutant metastatic lung adenocarcinoma Age Group: 71 years Sex: F Population Size: 1 Sources: |
|
Nausea | 240 mg 1 times / day multiple, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: multiple Dose: 240 mg, 1 times / day Sources: |
unhealthy, 71 years n = 1 Health Status: unhealthy Condition: EGFR L858R–mutant metastatic lung adenocarcinoma Age Group: 71 years Sex: F Population Size: 1 Sources: |
|
Vomiting | 240 mg 1 times / day multiple, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: multiple Dose: 240 mg, 1 times / day Sources: |
unhealthy, 71 years n = 1 Health Status: unhealthy Condition: EGFR L858R–mutant metastatic lung adenocarcinoma Age Group: 71 years Sex: F Population Size: 1 Sources: |
|
Diarrhea | 58% | 240 mg 1 times / day steady, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: steady Dose: 240 mg, 1 times / day Sources: Page: 53 |
unhealthy n = 13 Health Status: unhealthy Condition: NSCLC Sex: M+F Population Size: 13 Sources: Page: 53 |
Rash | 60% | 240 mg 1 times / day steady, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: steady Dose: 240 mg, 1 times / day Sources: Page: 53 |
unhealthy n = 13 Health Status: unhealthy Condition: NSCLC Sex: M+F Population Size: 13 Sources: Page: 53 |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Drug as perpetrator
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
major | ||||
no | ||||
no | ||||
yes | ||||
yes |
Tox targets
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000PharmR.pdf#page=51 Page: 51.0 |
||||
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/208065Orig1s000PharmR.pdf#page=53 Page: 53.0 |
Sample Use Guides
In Vitro Use Guide
Sources: https://www.ncbi.nlm.nih.gov/pubmed/26515464
Osimertinib inhibited cell lines harboring classic EGFR mutations, exon 19 deletions (PC-9) and L858R (H3255) with IC50 values 17 nM and 4 nM, respectively
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EMA ASSESSMENT REPORTS |
TAGRISSO (AUTHORISED: CARCINOMA, NON-SMALL-CELL LUNG)
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ACTIVE MOIETY
SUBSTANCE RECORD