What is Tagrisso (osimertinib) for?
Tagrisso (osimertinib) is a kinase inhibitor indicated for the treatment of patients with a specific type of lung cancer (metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC))1,2,3:
as first-line treatment of patients whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations1,8.
as second line treatment of patients whose disease has progressed on or after EGFR TKI therapy1,2,3.
How does Tagrisso (osimertinib) work?
The activity of the epidermal growth factor receptor (EGFR) normally controls growth and division of cells. In lung cancer cells, the EGFR is often overactive, causing uncontrolled division of cancer cells. By blocking the EGFR, osimertinib helps to reduce the growth and spread of the cancer. Unlike most other tyrosine kinase inhibitors, Tagrisso (osimertinib) is active against cancer cells with the T790M mutation in the EGFR gene4.
Where has Tagrisso (osimertinib) been approved?
Tagrisso (osimertinib) has been approved for advanced or metastatic NSCLC in patients with epidermal growth factor receptor (EGFR) T790M mutation by the following regulatory agencies in the following regions:
Food and Drug Administration (FDA), USA:
November 13, 2015, with accelerated approval (second-line treatment)5
March 30, 2017, with regular approval (second-line treatment)6
April 18, 2018, as a first line treatment7
European Medical Agency (EMA), European Union:
- February 2, 2016 (second-line treatment)4
- June 11, 2018 (first-line treatment)8
Therapeutic Goods Administration (TGA), Australia, August 3, 2016 (second line treatment)3
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Tagrisso (osimertinib) taken?
The standard dosage is:
Complete information about Tagrisso (osimertinib) dosage and administration can be found in the official prescribing information listed in our resources section1,2,3.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known side effects or adverse reactions of Tagrisso (osimertinib)?
Common adverse reactions
The most common adverse reactions listed in the prescribing information include1:
- dry skin
- nail toxicity
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include1:
- interstitial lung disease (ILD)/pneumonitis
- heart rate disturbances (QTc Interval Prolongation)
- keratitis (inflammation of the cornea of the eye).
Use in a specific population
Tagrisso (osimertinib) can be fatal for a fetus, it is advised to avoid pregnancies during treatment and for 6 weeks after the final dose. Men are advised to use effective contraception for 4 months, after the last dose1. Do not breastfeed1.
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information1,2,3.