First-line TAGRISSO delivered consistent results across all patient types2
Subgroup analyses of progression-free survival
First-line TAGRISSO reduced the risk of progression or death across all prespecified subgroups*, including patients with or without CNS metastases2
*Exploratory analysis. Subgroup analysis showed consistent results in additional subgroups not pictured here (WHO performance status, EGFR mutation by ctDNA, centrally confirmed EGFR mutation).
Adapted from: Soria et al. N Engl J Med. 2018.
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.1-3
- The primary endpoint of the study was PFS based on investigator assessment (according to RECIST v1.1)
- Secondary endpoints included overall response rate, duration of response, overall survival
POSSIBLE SERIOUS ADVERSE REACTIONS
Interrupt or discontinue treatment for certain uncommon adverse reactions1
a Adverse reactions graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0).
† QTc=QT interval corrected for heart rate.
This information does not replace any guidance or protocol given by your institution for managing patients with these symptoms. These are not all the possible side effects patients may experience. Encourage patients to report any and all side effects to their HCPs. They may also report side effects to the FDA at 1-(800)-FDA-1088 or www.fda.gov/medwatch.
MANAGING SIDE EFFECTS
Most common side effects with TAGRISSO
Most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite.1
Tips for managing the most common side effects
Educating patients and their caregivers about monitoring for potential uncommon adverse reactions is important. What follows are some helpful tips you may share for managing some of the most common side effects patients taking TAGRISSO may experience. These tips are not a substitute for medical advice from the patient’s healthcare team. Encourage patients to report any and all side effects they may have.
A common side effect of TAGRISSO is skin rash. It may appear on the face, upper chest, and back. It may look red with little bumps and may get worse if skin is exposed to sunlight. Patients may also experience other skin changes such as skin dryness and itching.4
Advise patients to protect their skin by4:
Using gentle skin cleansers
Avoiding the sun when possible
Wearing a hat
Regularly using alcohol-free moisturizers and sunscreen (SPF 30)
Wearing a hat
Encouraging them to talk to their HCP about any rashes they may have. The HCP may prescribe a cream or an anti-inflammatory/steroid
Diarrhea is another common mild or moderate (Grade 1 or 2)* side effect, and can usually be managed by doing the following4:
Eating small, frequent meals consisting of bland foods (eg, toast, white rice, crackers, eggs)
Using antidiarrheal medications as indicated
Contacting healthcare provider right away if diarrhea worsens
*Grade 1 (mild): no symptoms or mild symptoms, no intervention required; Grade 2 (moderate): minimal intervention indicated.5
First-line TAGRISSO offers convenient, once-daily dosing, with or without food
One 80-mg tablet, orally, once a day
TAGRISSO tablets may be taken with or without food
- TAGRISSO is also available as a 40-mg tablet for patients who may need a dose reduction
- Patients should be instructed not to make up the dose if a dose is missed, and to take the next dose as scheduled
Please see the full Prescribing Information for more information on dosing, including how to take TAGRISSO for patients who may have difficulty swallowing solids.
Helping patients access the care they need
The AstraZeneca Access 360TM program provides personal support to connect patients to affordability programs and streamline access and reimbursement for TAGRISSO® (osimertinib). To learn more about Access 360, please call 1-844-ASK-A360 (1-844-275-2360) or visit www.MyAccess360.com.
AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies.
References: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018. 2. 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. 3. 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 [protocol]. 4. Hirsh V. Managing treatment-related adverse events associated with EGFR tyrosine kinase inhibitors in advanced non-small-cell lung cancer. Curr Oncol. 2011;18(3):126-138. 5. Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed March 15, 2018.