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Prescribing Information | Indication | Important Safety Information
TAGRISSO Logo View final TAGRISSO Overall Survival results here › 
Dear Health Care Provider,
In the FLAURA trial, TAGRISSO showed superior progression‑free survival (PFS), with a median PFS of 18.9 months vs 10.2 months for erlotinib or gefitinib (HR=0.46 [95% CI: 0.37-0.57]; P<0.0001).1
First-line TAGRISSO is now the only choice for median Overall Survival beyond 3 years, as seen in a global phase 3 randomized study, demonstrating statistically significant and clinically meaningful superiority vs erlotinib and gefitinib.2 First-line TAGRISSO delivered a median Overall Survival of 38.6 months vs 31.8 months for erlotinib/gefitinib, extending survival by nearly 7 months (HR=0.799 [95% CI: 0.641-0.997]; P<0.0001).2 At 3 years, 54% of patients were still alive on first-line TAGRISSO vs 44% on erlotinib/gefitinib.2
TAGRISSO is indicated for the first-line treatment of metastatic EGFRm non-small cell lung cancer (NSCLC).
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65% (n=180) of patients in the erlotinib/gefitinib arm received any second-line therapy, of whom 47% (n=85) crossed over to TAGRISSO.2
View final TAGRISSO Overall Survival results here
FLAURA study design: Randomized, double-blind, active-controlled trial in 556 patients with metastatic EGFRm NSCLC who had not received prior systemic treatment for advanced disease. Patients were randomized 1:1 to either TAGRISSO (n=279; 80 mg orally, once daily) or EGFR-TKI comparator (n=277; gefitinib 250 mg or erlotinib 150 mg orally, once daily). All US patients in the comparator arm received erlotinib. Crossover was allowed for patients in the EGFR-TKI comparator arm at confirmed progression if positive for the EGFR T790M resistance mutation. Patients with CNS metastases not requiring steroids and with stable neurologic status were included in the study. The primary endpoint of the study was PFS based on investigator assessment (according to RECIST v1.1). Secondary endpoints included OS, ORR, and DoR.1,3-4
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.
Please see complete Prescribing Information including Patient Information.
You may report side effects related to AstraZeneca products by clicking here.
References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019. 2. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis [oral presentation]. Presented at: European Society of Medical Oncology; September 27-October 1, 2019; Barcelona, Spain. Abstract LBA5. 3. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR‑mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125. 4. Soria JC, Ohe Y, Vansteenkiste J, et al; FLAURA Investigators. Osimertinib in untreated EGFR‑mutated advanced non‑small‑cell lung cancer. N Engl J Med. 2018;378(2):113‑125 [protocol].
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For more information about TAGRISSO, please visit
This product information is intended for US health care professionals only.
TAGRISSO is a registered trademark of the AstraZeneca group of companies.
©2020 AstraZeneca. All rights reserved. US-39061 Last Updated 4/20
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