Tagrisso

RSS

osimertinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Tagrisso is a medicine for treating a lung cancer called non-small cell lung cancer (NSCLC).

It is used on its own in patients whose cancer cells have certain mutations (changes) in a gene for a
protein called EGFR.

• In patients whose cancer cells have genetic changes known as Ex19del or L858R and whose
cancer has not spread to other organs and has been completely removed by surgery, the
medicine is given to help prevent the cancer from coming back (adjuvant therapy).

• In patients whose cancer cells have mutations known as ‘activating mutations’ and whose
cancer is advanced or has spread, Tagrisso is given as the first treatment.

• In patients whose cancer cells have T790M mutations and whose cancer is advanced or has
spread, the medicine may be given after other treatments.

Tagrisso contains the active substance osimertinib.

This EPAR was last updated on 20/11/2023

Authorisation details

Product details
Name
Tagrisso
Agency product number
EMEA/H/C/004124
Active substance
osimertinib mesilate
International non-proprietary name (INN) or common name
osimertinib
Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
L01XE
Accelerated assessmentAccelerated assessment

This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
01/02/2016
Contact address
SE-151 85 Södertälje
Sweden

Product information

28/09/2023 Tagrisso - EMEA/H/C/004124 - II/0052

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

  • Other antineoplastic agents

  • Protein kinase inhibitors

Therapeutic indication

TAGRISSO as monotherapy is indicated for:

- the adjuvant treatment after complete tumour resection in adult 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

- the first-line treatment of adult patients NSCLC with activating EGFR mutations.
- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

TAGRISSO as monotherapy is indicated for:
- the adjuvant treatment after complete tumour resection in adult 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.
- the first-line treatment of adult patients with locally advanced or metastatic NSCLC with activating EGFR mutations.
- the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Assessment history

Changes since initial authorisation of medicine

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