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TOP NEWS: AstraZeneca celebrates Tagrisso approval and new data

ALN

AstraZeneca PLC on Monday announced new study data and a new approval for its cancer medication Tagrisso.

The Cambridge-based pharmaceutical company reported positive analysis from its Laura phase III trial for Tagrisso in lung cancer.

The treatment, following chemoradiotherapy, showed a ‘meaningful improvement in progression-free survival’ for a group of sufferers of non-small cell lung cancer, versus those in the placebo group.

Overall survival data showed a ‘favourable trend’ for Tagrisso, but Astra noted the data ‘were not mature’ at the time of the analysis. The trial will continue to assess overall survival as a secondary endpoint.

Separately, the firm announced Tagrisso with chemotherapy received US approval from the Food & Drug Administration for use in locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.

Further, Astra noted its biologics licence application for datopotamab deruxtecan has been accepted by the FDA.

The application, made alongside Tokyo-based pharmaceutical firm Daiichi Sankyo Co Ltd, concerned the drug’s use in the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer who have received prior systemic therapy.

Susan Galbraith, executive vice president, Oncology research & development at AstraZeneca said: ‘Datopotamab deruxtecan has the potential to offer patients with previously treated advanced nonsquamous non-small cell lung cancer an effective and tolerable alternative to conventional chemotherapy. With regulatory discussions ongoing around the world and a parallel submission underway in the US in breast cancer, this is only the beginning of our efforts to make this novel treatment available to patients as quickly as possible.’

Astra shares rose 3.9% to 10,489.12 pence each on Monday morning in London, while Daiichi Sankyo shares closed 0.1% lower at JP¥4,873.00 each in Tokyo.

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