Tagrisso launch?

When did Tagrisso (osimertinib) launch?

Tagrisso (osimertinib) was first approved by regulators in the U.S. in 2015, which is typically treated as its market launch timeframe.[1]

What was Tagrisso’s original approval for?

Tagrisso was approved for patients with metastatic EGFR T790M mutation–positive non-small cell lung cancer (NSCLC) whose disease had progressed on or after EGFR TKI therapy.[1]

When did Tagrisso expand to earlier-line settings?

After the initial 2015 approval, Tagrisso later received approvals in earlier treatment lines and additional disease settings, including broader use in EGFR-mutated metastatic NSCLC.[1]

Was Tagrisso launch the same worldwide?

No. Approval dates and rollout timing differ by country based on each regulator’s review process and local label requirements. The U.S. approval in 2015 is one anchor point for the product launch timeline.[1]

Sources

1. https://www.accessdata.fda.gov/drugsatfda_docs/label/