TAGRISSO (osimertinib) is indicated for:
EGFR Mutation-positive (non-small cell lung cancer) NSCLC
Adjuvant:
- As adjuvant therapy after tumour resection in patients with stage IB-IIIA* non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Metastatic (monotherapy):
- For the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations).
Unresectable Stage III:
- For the treatment of patients with locally advanced, unresectable (stage III) NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations) and whose disease has not progressed during or following platinum based chemoradiation therapy
This indication has been issued market authorization with conditions, pending the results of trials to verify its clinical benefit. Patients should be advised of the nature of the authorization. For further information for TAGRISSO please refer to Health Canada’s Notice of Compliance with conditions - drug products web site: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/notice-compliance/conditions.html
Marketing authorization with conditions was based on the primary efficacy endpoint of progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in subsequent analyses.
Metastatic (in combination with chemotherapy):
- TAGRISSO is indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
For the above indications, a validated test is required to identify EGFR mutation-positive status prior to treatment.
EGFR T790M Mutation-Positive NSCLC
- TAGRISSO is also indicated for the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
A validated test is required to identify EGFR T790M mutation-positive status prior to treatment.
Marketing authorization was based on results from a randomized Phase III trial (AURA3) demonstrating that TAGRISSO is superior to chemotherapy in prolonging progression-free survival (PFS) as assessed by investigator using RECIST v1.1.
Which NSCLC patients are eligible for TAGRISSO?
TAGRISSO clinical trial program included patients with NSCLC Stages IB to IV
Patient populations studied
* According to American Joint Committee on Cancer (7th edition).
EGFRm, epidermal growth factor receptor mutation-positive; NSCLC, non-small cell lung cancer; TKI, tyrosine kinase inhibitor.
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HCP Resources
The AstraZeneca Oncology Patient Support Program
We are proud to offer the AstraZeneca Oncology Patient Support Program (PSP) — a patient-focused initiative designed to provide financial and medication support for patients who have been prescribed TAGRISSO. For program inquiries and more information call 1-877-280-6208 (8am to 8pm EST Monday to Friday) or speak with your AstraZeneca Sales Representative.
Patient & Caregiver Resources
Safety Information for TAGRISSO
Clinical use:
Geriatric patients (≥65 years of age) reported more Grade 3 or higher adverse reactions compared to younger patients (11% versus 9%) with TAGRISSO monotherapy in the ADAURA, FLAURA, FLAURA2 (monotherapy arm), and AURA trials (n=1,813). Regarding children less than 18 years of age, no data are available; therefore, TAGRISSO is not indicated for pediatric use.
Most serious warnings and precautions:
Treatment: Treatment with TAGRISSO (osimertinib) should be initiated by a qualified physician experienced in the use of anticancer therapies.
Interstitial lung disease (e.g. pneumonitis), including fatal cases.
QT interval prolongation: Avoid in patients with congenital long QT syndrome. TAGRISSO is also not recommended in patients who are taking medicinal products known to prolong the QTc interval. Withhold in patients who develop a QTc (corrected QT) interval >500 ms on at least 2 separate ECGs (electrocardiograms) until QTc interval <481 ms or recovery to baseline. If baseline QTc ≥481 ms, resume treatment at reduced dose. Permanently discontinue for patients who develop QTc interval prolongation in combination with any of the following: Torsade de pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia.
Left ventricular dysfunction and cardiomyopathy: Some cases of cardiomyopathy were fatal. Conduct cardiac monitoring and left ventricular ejection fraction (LVEF) assessment at baseline and during treatment in patients with cardiac risk factors receiving TAGRISSO monotherapy and in all patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy. Discontinuation of treatment with TAGRISSO should be considered in patients who develop congestive heart failure.
Hematologic: Rare reports of aplastic anemia (some cases had a fatal outcome). Before initiating treatment, advise patients for signs and symptoms of aplastic anemia including persistent fever, bruising, bleeding, pallor. If these signs and symptoms develop, interrupt treatment and closely monitor patients. Discontinue treatment in confirmed aplastic anemia.
Other relevant warnings and precautions:
- EGFR (epidermal growth factor receptor) mutation-positive status (EGFR exon 19 deletions or exon 21 [L858R] substitution mutations).
- EGFR T790M mutation status.
- Drug interactions such as strong CYP3A4 inducers and concomitant medications with disposition dependent upon BCRP (breast cancer resistant protein) or P-gp (P-glycoprotein) and with narrow therapeutic indices.
- Driving or operating machinery.
- Keratitis; contact lens use.
- Pregnant women.
- Women of childbearing potential and males with female partners of reproductive potential.
- Breast-feeding mothers.
- Severe hepatic impairment.
- Severe and end-stage renal impairment.
- Electrolyte levels.
- Skin and subcutaneous tissue disorders including rash, dry skin, paronychia, pruritus, palmar-plantar erythrodysesthesia syndrome, alopecia, erythema multiforme, bullous and exfoliative skin disorders, such as rare, non-fatal Stevens-Johnson syndrome, and toxic epidermal necrolysis.
- Increased blood CPK levels, myositis, and rhabdomyolysis.
- Radiation pneumonitis.
For more information:
Please consult the Product Monograph for important information relating to adverse reactions, drug interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-668-6000.
NSCLC, non-small cell lung cancer; ECG, electrocardiogram; EGFR, epidermal growth factor receptor; TKI, tyrosine kinase inhibitor; BCRP, breast cancer resistant protein; P-gp, P-glycoprotein.
References:
- PrTAGRISSO® Product Monograph. AstraZeneca Canada Inc. April 23, 2025.
- Data on file.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.7.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed August 8, 2024.*
* 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.