AstraZeneca’s Tagrisso Receives FDA Approval for Nonsmall-Cell Lung Cancer

The FDA has approved AstraZeneca’s blockbuster oncology drug Tagrisso (osimertinib) as an adjuvant therapy after surgical removal of tumors in patients with nonsmall-cell lung cancer (NSCLC) with a specific genetic mutation.

The approval was supported by study results in which patients whose tumors had epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations had an 80 percent decrease in the chance of disease recurrence compared with the placebo group.

Tagrisso is AstraZeneca’s largest-selling medicine, earning approximately $3.2 billion globally in 2019.