To make sure you continue to receive this e-newsletter, please add info@iononline.com to your address book.

specialty-spotlight-hero
View Prescribing Information, Indications,
and Important Safety Information
TAGRISSO® (osimertinib)
Dear Amy Gonsuron,
TKIs and IO play different roles in the treatment of lung cancer.
In the first-line treatment of metastatic EGFRm NSCLC, EGFR TKIs are recommended. The National Comprehensive Cancer Network® (NCCN®) has designated osimertinib (TAGRISSO) as the only preferred, category 1 first-line therapy option for patients with metastatic EGFRm NSCLC.1* The NCCN does not recommend IO as a first-line treatment for EGFRm NSCLC, regardless of PD-L1 expression.
Scroll down to see a video of leading oncologists discussing this important treatment paradigm.
*This preferred designation is based on efficacy, safety, and evidence.
NCCN Guidelines® do not endorse specific testing modalities or techniques for biomarker tests.
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.
SELECT SAFETY INFORMATION
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
Watch the moderated discussion between Dr Jack West,
Dr Hatim Husain, and Dr Rachel Sanborn at TagrissoHCP.com
First-line TAGRISSO: A new standard of care
IO, immunotherapy; TKI, tyrosine kinase inhibitor.
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). 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.2,4
Visit TagrissoHCP.com to learn more   >
IMPORTANT SAFETY INFORMATION
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
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
INDICATION
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 the complete Prescribing Information including Patient Information.
You may report side effects related to AstraZeneca products by clicking here.
References:
1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC V.3.2019. © National Comprehensive Cancer Network, Inc. All rights reserved. Accessed January 22, 2019. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
2. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018.
3. Data on file, US-24835. EGFR TKI prescription data from Flatiron Health EHR-derived database and Ipsos US Oncology Monitor (September 2018, 86 physicians, all data collected online). Ipsos data © Ipsos 2018, all rights reserved. AstraZeneca Pharmaceuticals LP; 2018.
4. Soria JC, Ohe Y, Vansteenkiste J, et al. Osimertinib in untreated EGFR-mutated advanced non-small-cell lung cancer. N Engl J Med. 2018;378(2):113-125.
This product information is intended for US Health Care Professionals only.
TAGRISSO is a registered trademark of the AstraZeneca group of companies.
©2019 AstraZeneca. All rights reserved. US-25394 Last Updated 2/19
AstraZeneca Logo

Salesforce MC
This email was sent by: AmerisourceBergen
1300 Morris Dr, Chesterbrook, PA, 19087 US


Privacy Policy

Update Profile      Manage Subscriptions        Unsubscribe