EMA Recommends Extension of Indications for Osimertinib

New indication concerns treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations

Date: 18 Dec 2024

Topics:

Targeted Therapy; Molecular Oncology

Tumour Site:

Non-Small Cell Lung Cancer

On 14 November 2024, 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 treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy.

For information, the full indications for TAGRISSO will be as follows (new indication in bold):

Tagrisso as monotherapy is indicated for:

the adjuvant treatment after complete tumour resection in adult patients with stage IBIIIA NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum based chemoradiation therapy.
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.

Tagrisso is indicated in combination with:

pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.

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 made 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.