FDA approves new use for Tagrisso

The US Food and Drug Administration (FDA) has approved a new indication for AstraZeneca’s (LSE: AZN) Tagrisso (osimertinib), which is already the UK pharma major’s best-selling drug with second-quarter 2024 revenues of $1.6 billion,

Tagrisso is now authorized for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

A similar indication expansion was granted for Tagrisso by the European regulator in July this year.