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AstraZeneca PLC on Monday said that its new drug application for Tagrisso has been granted priority review in the US, after trial results extended progression-free survival. The Cambridge-based pharmaceutical firm’s supplemental application was accepted and granted review following the FLAURA2 Phase III trial. Trial results showed that Tagrisso in combination with chemotherapy reduced the risk of disease progression or death by 38% in adult patients, when compared to Tagrisso monotherapy. The drug, otherwise known as osimertinib, is designed to treat adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer. The US Food & Drug Administration granted priority review for Tagrisso on the basis of these results, which were found to have extended median progression-free survival by nearly nine months versus standard of care. According to AstraZeneca, the FDA only grants priority review to applications for medicines that, if approved, would offer ‘significant improvements over available options’ by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The prescription drug user fee act date, the FDA action date for their regulatory decision, is expected in the first quarter of next year. ‘The FLAURA2 results reinforce Tagrisso as a backbone of standard of care in 1st-line EGFR-mutated non-small cell lung cancer, providing patients with an additional nine months of median progression-free survival when combined with chemotherapy,’ said Susan Galbraith, executive vice president of oncology research and development at AstraZeneca. Galbraith added: ‘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.’ AstraZeneca shares were trading 0.9% lower at 10,878.00 pence each in London on Monday morning. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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