FDA Approves AstraZeneca's Tagrisso for EGFR-Mutated Lung Cancer

AstraZeneca's (AZ) Tagrisso (osimertinib) has received approval from the US Food and Drug Administration (FDA) to treat a newly identified subset of lung cancer patients. This epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor is now specifically authorized for the treatment of adult patients with unresectable, stage 3 non-small cell lung cancer (NSCLC) whose disease exhibits EGFR exon 19 or exon 21 mutations and has not advanced during or following concurrent or sequential platinum-based chemoradiation therapy.

The FDA's decision is grounded in favorable outcomes from the advanced LAURA trial. In this study, Tagrisso demonstrated an 84% reduction in the risk of disease progression or death compared to a placebo. Patients treated with Tagrisso showed a median progression-free survival of 39.1 months, significantly higher than the 5.6 months observed in the placebo group. Additionally, the safety and tolerability profiles of Tagrisso were consistent with previous data on the drug.

In the United States, lung cancer is diagnosed in more than 200,000 individuals each year, with NSCLC accounting for up to 85% of these cases. Among NSCLC patients in the US, approximately 15% have EGFR mutations, making them particularly responsive to treatment with EGFR-tyrosine kinase inhibitors, which target the cell-signalling pathways responsible for tumor growth.

Tagrisso is already approved for patients with EGFR mutations in various settings. It is used as a monotherapy and in combination with chemotherapy for first-line metastatic treatment and as an adjuvant therapy for early-stage disease. Dave Fredrickson, executive vice president of the oncology business unit at AZ, emphasized the significance of the latest approval by noting that it fulfills an unmet need for patients with these mutations, who previously had no options for targeted therapy. He also highlighted the profound impact of Tagrisso demonstrated in the LAURA trial and expressed optimism about the benefits it offers to patients across all stages of EGFR-mutated NSCLC.

This announcement follows closely on the heels of the FDA's recent approval of AZ’s Imfinzi (durvalumab) regimen for the treatment of resectable early-stage (stage 2A to 3B) NSCLC without known EGFR mutations or anaplastic lymphoma kinase rearrangements. The drug is now authorized in the US for treating both resectable and unresectable NSCLC. It can be used in conjunction with neoadjuvant chemotherapy before surgery and as an adjuvant monotherapy post-surgery.

In summary, this new approval for Tagrisso marks a significant advancement in the treatment of NSCLC, providing a targeted therapy option for patients with specific genetic mutations and reinforcing the drug’s role as a cornerstone in the management of EGFR-mutated lung cancer.