The EMA recommends expanding the indication for osimertinib

Release date: 2024-12-24 11:07:08     Recommended: 598

The new indication involves the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer with tumors with EGFR exon 19 deletion or exon 21 (L858R) replacement mutations.

On November 14, 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the marketing authorization terms of the drug osimertinib (Tagrisso).

The marketing authorization holder for this drug is AstraZeneca AB.

CHMP has adopted a new metric, which looks like this:

Tagrisso is indicated as monotherapy for the treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletion or exon 21 (L858R) replacement mutations and whose disease has not progressed during or after platinum-based chemoradiotherapy.

For information, the full indications for TAGRISSO are as follows (new indications are shown in bold):

Tagrisso as a monotherapy is indicated for:

Adjuvant therapy after complete resection of tumor in adult patients with stage IBIIIA NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutations.

To treat adult patients with locally advanced, unresectable NSCLC whose tumors have EGFR exon 19 deletion or exon 21 (L858R) substitution mutations and whose disease has not progressed during or after platinum-based chemoradiotherapy.

First-line treatment for adult patients with locally advanced or metastatic NSCLC with EGFR activating mutations.

Treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC.

Tagrisso is used in conjunction with the following products:

Pemetrexed and platinum-based chemotherapy are used as first-line treatment for adult patients with advanced NSCLC whose tumors have EGFR exon 19 deletion or exon 21 (L858R) replacement 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 will be available in all EU official languages following the European Commission's decision on changes to the marketing authorization.

The issuance of a summary of the affirmative opinion does not affect the Committee's decision, which is typically published 67 days after the opinion is adopted.