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TAGRISSO® (osimertinib)

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Summary of Product Characteristics

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This product information is intended for non-US and non-UK Healthcare Professionals only.

TAGRISSO is a registered trademark of the AstraZeneca group of companies.

©2019 AstraZeneca. All rights reserved.

Date of Prep: August 2019 VEEVA ID: Z4-19198 Date of Next Approval: August 2020

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For healthcare professionals only.

First-line TAGRISSO^®:
The only treatment with median overall survival beyond 3 years¹

In a global Phase III study of advanced EGFRm NSCLC²

First-line TAGRISSO delivered an unprecedented 18.9 months median PFS^2,3
- In a global Phase III study of advanced EGFRm NSCLC
- HR=0.46 (95% CI: 0.37, 0.57; P<0.0001)

Study design

FLAURA was a global, Phase III, double-blind, randomised study of 556 patients with locally advanced or metastatic NSCLC and EGFRm disease (exon 19 deletion or L858R substitution mutations) who had not received prior anticancer treatment. Patients were randomised 1:1 to either TAGRISSO (n=279; 80 mg, orally, once daily) or an EGFR-TKI comparator (n=277; gefitinib 250 mg or erlotinib 150 mg, orally, once daily). Crossover to second-line TAGRISSO was allowed for patients in the EGFR-TKI comparator arm upon centrally confirmed disease progression with confirmed EGFR T790M mutation. Patients with stable, asymptomatic CNS metastases were allowed in the study. The primary endpoint of the study was PFS by investigator assessment (according to RECIST v1.1). Secondary endpoints included OS, ORR, and DoR.^2,3

TAGRISSO AS MONOTHERAPY IS INDICATED FOR:

the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations.
the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

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Safety considerations^*

If Interstitial Lung Disease (ILD) is diagnosed, TAGRISSO should be permanently discontinued and appropriate treatment initiated as necessary²
Periodic monitoring with electrogardiograms (ECGs) and electrolytes should be considered in patients with congestive heart failure, electrolyte abnormalities, or those who are taking medicinal products that are known to prolong the QTc interval. Treatment should be withheld in patients who develop a QTc interval >500 msec on at least 2 separate ECGs, and TAGRISSO should be permanently discontinued in patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia²
Across clinical trials, Left Ventricular Ejection Fraction (LVEF) decreases ≥10% and a drop to <50% occurred in 3.9% (35/908) of patients treated with TAGRISSO who had baseline and at least one follow-up LVEF assessment. Based on the available clinical trial data, it is not possible to determine a casual relationship between effects on changes in cardiac contractility and TAGRISSO. In patients with cardiac risk factors and those with conditions that can affect LVEF, cardiac monitoring, including an assessment of LVEF at baseline and during treatment, should be considered. In patients who develop relevant cardiac signs/symptoms during treatment, cardiac monitoring including LVEF assessment should be considered²
In patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, and/or red eye should be referred promptly to an ophthalmology specialist²
Elderly patients (>65 years) or patients with low body weight (<50 kg) may be at increased risk of developing adverse events of Grade 3 or higher. Close monitoring is recommended in these patients²
Based on its mechanism of action and preclinical data, TAGRISSO may cause foetal harm when administered to a pregnant woman. TAGRISSO should not be used during pregnancy unless the clinical condition of the woman requires treatment with TAGRISSO²

*Please refer to product labelling for more information.

REFERENCES: 1. 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. 2. AstraZeneca Pharmaceuticals. TAGRISSO^® (osimertinib). Summary of Product Characteristics, 2018. 3. Soria J-C, 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.

AstraZeneca Global Corporate Site
Privacy Notice
Legal Statement
Cookies
Site Map
Site Map
EU SmPC
Adverse Event Reporting

This product information is intended for non-US and non-UK Healthcare Professionals only.

TAGRISSO is a registered trademark of the AstraZeneca group of companies.

©2019 AstraZeneca. All rights reserved.

Date of Prep: September 2019 VEEVA ID: Z4-20244 Expiry date: September 2020

This product information is intended for non-US and non-UK Healthcare Professionals only.

TAGRISSO is a registered trademark of the AstraZeneca group of companies.

©2019 AstraZeneca. All rights reserved.

Date of Prep: September 2019

VEEVA ID: Z4-20244 Expiry date: September 2020