AstraZeneca’s Tagrisso Expands EU Approval for NSCLC Treatment

EU Approval:
AstraZeneca's Tagrisso (osimertinib) has been approved by the European Commission for the treatment of adults with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or after platinum-based chemoradiation therapy13.

Clinical Trial Results:
The approval is based on the outcomes from the LAURA Phase III trial, which showed that Tagrisso significantly decreased the risk of disease progression or mortality by 84% compared to placebo, with a median progression-free survival (PFS) of 39.1 months1.

Expanded Indications:
This approval marks the fifth authorization for Tagrisso based on the LAURA trial outcomes, following recent approvals in the US, Australia, Switzerland, and South Korea. Regulatory reviews are ongoing in China, Japan, and other countries1.

Combination Therapy:
Tagrisso with the addition of pemetrexed and platinum-based chemotherapy has also been approved in the EU for the first-line treatment of adult patients with advanced EGFR-mutated NSCLC, based on the FLAURA2 Phase III trial results24.

Global Reach:
Tagrisso is approved as monotherapy in over 100 countries, including the EU, China, and Japan, for various indications including first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and adjuvant treatment of early-stage EGFRm NSCLC24.

Sources:

1. https://www.pharmaceutical-technology.com/news/astrazeneca-tagrisso-ec-nsclc/

2. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-plus-chemo-recommended-for-approval-in-eu.html

3. https://www.nasdaq.com/articles/azns-tagrisso-gets-approval-eu-expanded-use-nsclc

4. https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-with-the-addition-of-chemotherapy-approved-in-the-eu-as-new-1st-line-treatment-for-patients-with-egfr-mutated-advanced-lung-cancer.html