Tagrisso Receives EU Approval for Unresectable EGFR-Mutated Lung Cancer

Published: 26 Dec 2024

Author: Precedence Research

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The European Union recently approved Tagrisso for adult patients suffering from newly diagnosed, advanced, nonsurgical non-small cell lung cancer due to mutations. The drug, an EGFR inhibitor brought to the market by AstraZeneca, will be the first and only drug of its kind to receive approval for this specific indication. This represents an important milestone in the realm of precision oncology for patients suffering from the most aggressive types of malignancies. According to the LAURA Phase III data, Tagrisso reportedly reduced the risk of progression or death by 84% compared to a placebo. The median progression-free survival with Tagrisso was 39.1 months, compared to 5.6 months with the placebo. This approval thus brings hope to the historically underserved population, paving the way for more years of life and improving quality of life.

Breakthrough Approval for EGFR-Targeted Therapy

The results of Tagrisso in unresectable non-small cell lung cancer are very impressive. It is the first EGFR inhibitor prescribed for this disease, setting a benchmark standard in therapeutic intervention. Thus, the LAURA trial showed an impressive 84% reduction in progressive disease or death compared to a placebo, along with a median progression-free survival of 39.1 months. This demonstrates the urgent need for EGFR mutation testing at diagnosis and positions Tagrisso as the new standard-bearer for patient outcomes in unresectable NSCLC. Lung cancer is still one of the most frequently fatal cancers across Europe: 80%-85% of all lung cancers are categorized as the most common type—non-small cell lung cancer—of which only a minority, 10%-15%, are caused by mutations in EGFR. Therefore, early intervention using Tagrisso is of great importance for the majority of patients in that population.

Expert Opinions and Industry Perspective

Dr. Manuel Cobo, a specialist physician at Carlos Haya University Hospital in Malaga, Spain, applauded the approval as the first and only EGFR inhibitor licensed in the EU for this indication. He praised the significant 84% risk reduction in disease progression or death observed in the LAURA trial, which has set a new standard for outcomes. According to Dave Fredrickson, executive vice president of AstraZeneca's Oncology Business Unit, the importance of EGFR testing is underscored, and Tagrisso has become the backbone therapy for EGFR mutation-positive NSCLC. The safety profile of Tagrisso aligns with prior studies.

Global Recognition and Expansion

Tagrisso is one of the groundbreaking EU-approved drugs that promises to change the future of treatment for patients suffering from unresectable NSCLC with an EGFR mutation. The drug, approved in more than 100 countries, is used for the treatment of locally advanced or metastatic NSCLC with EGFR mutation-positive status and early EGFR-mutated NSCLC as a monotherapy. It is also approved in combination with chemotherapy for the first-line treatment of metastatic disease. Tagrisso's approval is a significant milestone in precision oncology because it sets a new standard for PFS and further emphasizes the relevance of EGFR testing. AstraZeneca has remained a leader in precision oncology innovations, giving patients renewed hope and solidifying its importance in managing EGFR-mutated NSCLC as a cornerstone therapy.