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AstraZeneca, Daiichi Sankyo hail US breakthrough therapy designation

ALN

AstraZeneca PLC and Daiichi Sankyo Co Ltd on Monday announced they have been granted a breakthrough therapy designation in the US to treat some sufferers of non-small cell lung cancer.

The Cambridge-based and Tokyo-based pharmaceutical companies said their datopotamab deruxtecan treatment has been granted breakthrough therapy designation in the US for adults with disease progression on or after treatment with an epidermal growth factor receptor tyrosine kinase inhibitor and platinum-based chemotherapy advanced EGFR-mutated non-small cell lung cancer.

Breakthrough therapy designation by the US Food & Drug Administration aims to quicken the development and regulatory review of a drug. The treatment is being jointly developed by AstraZeneca and Daiichi Sankyo.

‘The breakthrough therapy designation granted by the FDA underscores the significant unmet need for new treatments for patients with previously treated EGFR-mutated non-small cell lung cancer who have experienced disease progression,’ said Ken Takeshita, global head, research & development at Daiichi Sankyo.

He added: ‘Datopotamab deruxtecan has the potential to play an important role in improving outcomes and we look forward to working closely with the FDA to bring this medicine to patients as quickly as possible.’

AstraZeneca shares were 0.4% higher at 10,698.00 pence each on Monday morning in London, while Daiichi Sankyo shares closed 2.0% lower at JP¥4,590.00 in Tokyo.

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