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AstraZeneca PLC on Wednesday said a cancer drug it has helped develop to treat a form of breast cancer has been granted breakthrough therapy designation in the US.
Breakthrough therapy designations are handed out by the US Food & Drug Administration to drugs used to treat serious or life-threatening conditions. It is designed to quicken the regulatory approval process for these therapies.
AstraZeneca said the Enhertu drug, developed alongside Daiichi Sankyo Co Ltd, secured the US regulatory win. Daiichi Sankyo is a pharmaceutical company based in Tokyo, Japan.
Enhertu treats sufferers of unresectable or metastatic human epidermal growth factor receptor 2 breast cancer.
Unresectable tumours cannot be removed through surgery and metastasis is when cancers spread to other parts of the body. Human epidermal growth factor receptor 2 is a protein which promotes cancer cell growth.
‘Enhertu is a specifically engineered HER2-directed antibody drug conjugate,’ Astra explained.
Earlier in April, Astra said the drug received priority review from the FDA.
Shares in Astra were 0.5% higher at 10,380.00 pence each in London on Wednesday morning. Daiichi Sankyo shares rose 2.9% to JP¥3,037 each in Tokyo on Wednesday.
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