First-line TAGRISSO: Watch expert discussions and informational videos
Mechanism of Action See how first-line TAGRISSO works in the body. 8 min 40 sec.
Dr West & panel: What to know before choosing the appropriate treatment option
Dr Jack West and a panel of experts discuss the study data for IO therapies and EGFR TKIs in the first-line treatment of patients with metastatic EGFR mutation-positive NSCLC. They also review efficacy data for TAGRISSO® (osimertinib) from the FLAURA study. 11 min 59 sec.
Dr Hatim Husain: Managing a patient who has progressed on TAGRISSO® (osimertinib)
Dr Hatim Husain, Oncologist from the University of California, San Diego, uses a hypothetical patient case to highlight the multiple treatment options available after first-line TAGRISSO® (osimertinib). 7 min 44 sec.
Dr Balazs Halmos: TAGRISSO® (osimertinib) data from the FLAURA trial
Dr Balazs Halmos, Director of Thoracic Head and Neck oncology at Montefiore Albert Einstein Cancer Center, reviews the progression-free survival and overall survival results from the pivotal FLAURA trial of TAGRISSO. Watch Dr Halmos share an in-depth analysis of exploratory data in patient subgroups from the trial. 8 min 24 sec
FLAURA study: An expert’s view on updated results
Mark Socinski, MD, Executive Medical Director at AdventHealth Cancer Institute in Orlando, Florida, reports from ESMO 2019, where new data from the FLAURA study were presented. He also comments on the importance of having complete genomic information from comprehensive biomarker testing in metastatic EGFR-mutation positive NSCLC patients when making a treatment decision. 7 min 58 sec.
Implications of FLAURA Study Data
Mark Socinski, MD, Executive Medical Director at AdventHealth Cancer Institute in Orlando, Florida, gives his expert perspective on the latest data from the FLAURA study presented at ESMO 2019. He also speaks about the importance of biomarker testing in metastatic NSCLC and of identifying metastatic NSCLC patients with an EGFR mutation.
7 min 34 sec.
There are no contraindications for TAGRISSO
Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients; 0.3% 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 1479 TAGRISSO-treated patients in clinical trials, 0.8% were found to have a QTc >500 msec, and 3.1% 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 3% of the 1479 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 3.2% of 1233 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. 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 1479 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
Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity
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 (≥20%) adverse reactions, including laboratory abnormalities, were leukopenia, lymphopenia, thrombocytopenia, diarrhea, anemia, rash, musculoskeletal pain, nail toxicity, neutropenia, dry skin, stomatitis, fatigue, and cough
TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with 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 first-line treatment of adult 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 adult 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
For additional information, please see the complete Prescribing Information, including Patient Information.
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