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EMA Recommends Extension of Therapeutic Indications for Osimertinib

New indication concerns adjuvant treatment in patients with NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations
26 Apr 2021
Anticancer agents & Biologic therapy;  Lung and other thoracic tumours;  Personalised medicine

On 22 April 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product osimertinib (Tagrisso). 

The marketing authorisation holder for this medicinal product is AstraZeneca AB. 

The CHMP adopted a new indication as follows: 

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. 

For information, the full indications for Tagrisso as monotherapy will be as follows (new text in bold): 

  • the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA NSCLC whose tumours have 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. 

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. 

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

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