(Alliance News) - AstraZeneca PLC on Monday celebrated a breakthrough therapy designation for its cancer drug Tagrisso, aimed at treating a form of non-small cell lung cancer.

The Cambridge-based pharmaceutical company said its supplemental new drug application for Tagrisso has been accepted and granted priority review by the Food & Drug Administration in the US for the treatment of adult patients with unresectable, stage III epidermal growth factor receptor-mutated non-small cell lung cancer after chemoradiotherapy.

Astra said the decision was based on Laura Phase III trial results, which extended median progression-free survival by more than three years.

The FDA's regulatory decision is expected during the fourth quarter of 2024. If approved, Tagrisso will be indicated for patients with epidermal growth factor receptor-mutated non-small cell lung cancer whose tumours have exon 19 deletions or exon 21 mutations.

Further, Tagrisso received breakthrough therapy designation by the FDA. The designation speeds up the development and regulatory review of potential new medicines intended to treat a serious condition.

"Each year in the US, there are nearly 200,000 people diagnosed with lung cancer, and 80% to 85% of these patients are diagnosed with NSCLC, the most common form of lung cancer," Astra said.

Susan Galbraith, executive vice president at Oncology research & development at Astra, said: "Priority review of Tagrisso in this early-stage curative setting is important for patients who currently have no targeted treatments available. We look forward to close collaboration with the FDA on an accelerated path to bring Tagrisso to patients as a potential new standard of care as quickly as possible."

Astra shares were 0.3% higher at 12,592.00 pence each on Monday morning in London.

By Tom Budszus, Alliance News slot editor

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