For the treatment of metastatic EGFRm NSCLC
Optimal treatment starts with a full molecular profile
~1 in 3 patients with metastatic lung adenocarcinoma has an actionable mutation, a genetic alteration that1-4
One missed patient is one too many—test all your mNSCLC patients for actionable mutations like EGFR
Patients with mNSCLC should get EGFR testing, regardless of
SMOKING STATUS Up to 38% of EGFR mutations could be missed if patients with smoking history are not tested5,6*
GENDER ~1/3 of EGFR mutations could be missed if men are not tested7†
NCCN® recommends clinicopathologic features such as ethnicity, smoking status, or histology NOT be used to select patients for molecular testing14
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend14
Patients with an EGFR mutation may also express PD-L1
UP TO 70% OF EGFRm mNSCLC PATIENTS ALSO EXPRESS AT LEAST 1% PD-L117-21
No single-agent or combination immunotherapies are FDA-approved for treatment-naïve EGFRm mNSCLC patients22-24
*KEYNOTE-189, KEYNOTE-021 Cohort G, KEYNOTE-042, KEYNOTE-024, CHECKMATE 026, CHECKMATE 227, IMpower130, IMpower150. In the IMpower130 and IMpower150 trials, EGFRm positive patients were allowed only after progression on EGFR-TKI therapy or intolerance to EGFR TKI treatment.22-24
In mNSCLC, optimal treatment starts with knowing the driver of your patient’s disease
TAGRISSO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
TAGRISSO is designed to inhibit EGFR sensitizing and resistance mutations38-41
TAGRISSO is a third-generation, irreversible EGFR TKI designed to
||Study description: Eight (8) healthy male volunteers (age 52±8 years) were examined for ~90 minutes with PET imaging after single intravenous microdose (1.3 mcg; range 1.1-1.4 mcg) of 11C-labeled TAGRISSO. Concentrations of 11C-labeled TAGRISSO were also measured in arterial and venous blood and plasma. Brain MRI was acquired and used for co-registration of PET data and automatic delineation of regions of interest in the brain. PK parameters Cmax (brain), Tmax (brain) and AUC0–90 min brain/blood ratio were calculated. Safety and tolerability monitoring included recording of AEs, vital signs and ECG.44
ALK, anaplastic lymphoma kinase; BRAF, B-Raf proto-oncogene; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutant; IO, immunotherapy; L858R, substitution of lysine for arginine at amino acid position 858; mNSCLC, metastatic non-small cell lung cancer; NSCLC, non-small cell lung cancer; PD-L1, programmed death-ligand 1; ROS1, ROS proto-oncogene 1; TKI, tyrosine kinase inhibitor; T790M, substitution of threonine for methionine at position 790; WT, wild-type.
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38. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.
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There are no contraindications for TAGRISSO
Interstitial lung disease (ILD)/pneumonitis occurred in 3.9% of the 1142 TAGRISSO-treated patients; 0.4% of cases were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD is confirmed
Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 1142 TAGRISSO-treated patients in clinical trials, 0.9% were found to have a QTc >500 msec, and 3.6% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia
Cardiomyopathy occurred in 2.6% of the 1142 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.9% of 908 patients who had baseline and at least one follow-up LVEF assessment. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO
Keratitis was reported in 0.7% of 1142 patients treated with TAGRISSO in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist
Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed
Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose
Most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite
TAGRISSO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
TAGRISSO is indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
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