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AstraZeneca and Daiichi Sankyo’s Enhertu recommended for approval

ALN

AstraZeneca PLC and Daiichi Sankyo Co Ltd’s Enhertu has been recommended for approval in the EU on Friday.

Daiichi is a Tokyo-based pharmaceutical company. AstraZeneca is a Cambridge-based pharmaceutical firm.

Astra said Enhertu has been recommended for approval as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer whose tumours have an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

Enhertu, whose generic name is trastuzumab deruxtecan, is a specifically engineered HER2-directed antibody drug conjugate being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Susan Galbraith, executive vice president of Oncology Research & Development at AstraZeneca, said: ‘HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies. This milestone recognises the unmet need in the European Union and if approved, Enhertu will provide the first targeted treatment option for these patients.’

AstraZeneca shares were up 1.1% at 10,932.00 pence on Friday afternoon in London. Daiichi Sankyo closed up 0.2% at JP¥4,123.00 in Tokyo.

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