FDA gives AstraZeneca's Tagrisso the thumbs up for first-line treatment

AstraZeneca announced on Thursday that the US Food and Drug Administration has approved Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer, whose tumours have epidermal growth factor receptor mutations as detected by an FDA-approved test.

The FTSE 100 drugmaker said the approval was based on results from the Phase III FLAURA trial, which were presented at the European Society of Medical Oncology 2017 Congress and published in the New England Journal of Medicine.

“Today's FDA approval of Tagrisso in the first-line setting is an exciting milestone for patients and our company,” said Dave Fredrickson, executive vice president, head of the oncology business unit at AstraZeneca.

“Tagrisso delivered unprecedented median progression-free survival data across all pre-specified patient subgroups, including patients with or without CNS metastases, and could prolong the lives of more patients without their tumours growing or spreading.”

Dr Suresh S Ramalingam, the principal investigator of the FLAURA trial from the Winship Cancer Institute of Emory University in Atlanta, said the approval of osimertinib in the first-line setting represented a “major advance” in the treatment of patients with epidermal growth factor receptor mutations, and a “significant change” in the treatment paradigm.

“Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors.”

AstraZeneca said the FLAURA trial compared Tagrisso to current first-line tyrosine kinase inhibitors - erlotinib or gefitinib - in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

Tagrisso met the primary endpoint of progression-free survival.

Progression-free survival results with Tagrisso were said to have been consistent across all pre-specified patient subgroups, including in patients with or without central nervous system metastases.

Overall survival data were not mature at the time of the final PFS analysis.