New Tagrisso approval in EU

5 July 2024

Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Tagrisso (osimertinib) has won a new approval in the European Union (EU).

The epidermal growth factor receptor tyrosine kinase inhibitor has been approved alongside pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumors have exon 19 deletions or exon 21 (L858R) mutations.

This approval is based on results from the FLAURA2 Phase III trial, during which Tagrisso and chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the first-line global standard of care.

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