The US Food and Drug Administration (FDA) has granted a priority review to the supplemental new drug application (sNDA) filed by AstraZeneca for its Tagrisso (osimertinib) along with chemotherapy to treat adults with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Tagrisso is a third-generation, irreversible EGFR-TKI that demonstrated clinical efficacy against NSCLC, including central nervous system metastases.
The sNDA has been filed based on data from the FLAURA2 Phase III study, which expanded median progression-free survival by almost nine months compared with the standard of care.
Tagrisso plus chemotherapy was shown to lower the risk of disease progression or death by 38% against Tagrisso monotherapy.
FLAURA2 is an open-label, randomised, multi-centre, global study in the first-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC.
It enrolled 557 patients in 150 centres across 20 countries and regions, including the US, Europe, Asia and South America.
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AstraZeneca oncology research and development executive vice-president Susan Galbraith stated: “The FLAURA2 results reinforce Tagrissoas a backbone of standard of care in first-line EGFR-mutated non-small cell lung cancer, providing patients with an additional nine months of median progression-free survival when combined with chemotherapy.
“This option is particularly important for patients with a poorer prognosis, such as those with brain metastases. We look forward to working with the FDA on an accelerated timeline to bring this treatment regimen to patients as quickly as possible.”
In August 2023, the company received breakthrough therapy designation from the FDA for Tagrisso plus chemotherapy as a first-line treatment for adults with locally advanced or metastatic EGFRm NSCLC.
It was approved as monotherapy in more than 100 countries, including the US, Japan and China, and countries in the European Union.
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