AstraZeneca has announced that the US Food and Drug Administration has approved Tagrisso (osimertinib) with the addition of chemotherapy in adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The decision is based on the phase 3 FLAURA2 trial results published in the New England Journal of Medicine, which demonstrated extended median progression-free survival (PFS) by nearly 9 months versus standard of care.
Recently, AstraZeneca also announced positive high-level results from the phase 3 LAURA trial, a global study for Tagrisso patients with unresectable, stage 3 EGFRm NSCLC after chemoradiotherapy (CRT) compared with placebo after CRT. As of now, the LAURA results show:
- Tagrisso following chemoradiation demonstrated a statistically significant and highly clinically meaningful improvement in PFS.
- These results reinforce Tagrisso as a key player in delaying disease progression, offering potential benefits for patients without worsening their condition.