Tagrisso approved in US for unresectable, Stage III EGFR-mutated lung cancer
The US FDA has approved AstraZeneca's Tagrisso (osimertinib) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer. Approval follows chemoradiation therapy.
AstraZeneca's Tagrisso (osimertinib) has been approved in the United States for adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval is for patients whose disease has not progressed following concurrent or sequential platinum-based chemoradiation therapy (CRT).
The decision by the Food and Drug Administration (FDA) is based on results from the global Phase III LAURA trial. Data showed that Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Median progression-free survival (PFS) was 39.1 months for patients treated with Tagrisso, compared to 5.6 months for placebo.
Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, called the approval a major breakthrough. He highlighted that patients receiving Tagrisso in the LAURA trial lived without disease progression for over three years, underscoring the importance of early diagnosis and testing for EGFR mutations.
AstraZeneca stated that the approval addresses a critical need for patients with these mutations who previously lacked access to targeted therapy. Tagrisso is already approved for use in other stages of EGFR-mutated NSCLC, including adjuvant treatment for early-stage disease.