First-line indication for Tagrisso in USA

The US Food and Drug Administration has approved Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.

The approval is 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, said the drug’s maker, Anglo-Swedish major AstraZeneca (LSE: AZN)/

Thus far, Tagrisso has been limited to second-line patients with EGFR T790M mutation.  The drug generated sales of $955 million in 2017, but the new indication should be a significant factor in pushing revenue to the $4 billion a year target that AstraZeneca has predicted.