AZN's Tagrisso Gets Approval in the EU for Expanded Use in NSCLC

Core Insights - AstraZeneca's cancer drug Tagrisso has received EU approval for expanded use in non-small cell lung cancer (NSCLC) [10] - The approval is based on the phase III LAURA study, which demonstrated an 84% reduction in the risk of disease progression or death compared to placebo [6] - Tagrisso's sales reached $4.9 billion in the first nine months of 2024, reflecting a 15% year-over-year increase [16] Group 1: Approval and Indications - The eligible patient population for Tagrisso includes adults with locally advanced, unresectable NSCLC with specific EGFR mutations [1] - Tagrisso is now approved in the EU for five major indications based on the LAURA study, with ongoing reviews in other countries [2][10] - The drug is considered the standard of care for EGFR-mutated NSCLC in the first-line setting [11] Group 2: Clinical Data and Efficacy - The LAURA study showed a median progression-free survival of 39.1 months for Tagrisso-treated patients compared to 5.6 months for the placebo group [6] - The safety and tolerability profiles of Tagrisso were consistent with prior studies, with no new safety concerns identified [6] Group 3: Market Performance and Future Prospects - Tagrisso's sales growth is driven by strong demand as a first-line and adjuvant treatment [16] - AstraZeneca is evaluating Tagrisso in multiple-label expansion studies, which may further boost sales in the future [12] - AstraZeneca's shares have declined by 15% over the past three months, compared to a 17.4% decline in the industry [15]