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AstraZeneca PLC on Monday said that the EU’s Committee for Medicinal Products for Human Use, or CHMP, recommended its cancer drug Tagrisso as treatment for a form of lung cancer. The Cambridge, England-based pharmaceutical company said the recommended approval is for adults with locally advanced, unresectable non-small cell lung cancer whose tumours have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy. The recommendation is based on results from the Laura phase 3 trial which showed Tagrisso reduced the risk of disease progression or death by 84% compared to placebo. Median progression-free survival was 39.1 months in patients treated with Tagrisso compared to 5.6 months for placebo. ‘Today’s news reinforces Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer, meeting the critical unmet need for an effective targeted treatment option in the unresectable setting. Tagrisso has now demonstrated its benefit across all stages of EGFR-mutated lung cancer, representing a pivotal step in transforming care for patients who are urgently in need of innovative therapies that can help extend their lives,’ said Susan Galbraith, executive vice president, Oncology research & development at AstraZeneca. Tagrisso is currently approved as monotherapy in over 100 countries for several forms of non-small cell lung cancer. AstraZeneca shares were 0.8% lower at 9,900.73 pence each on Monday morning in London. Copyright 2024 Alliance News Ltd. All Rights Reserved.
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