23rd Oct 2023 08:45
(Alliance News) - AstraZeneca PLC on Monday said its Enhertu treatment has been approved by the European Commission to treat adult lung cancer patients.
The Cambridge-based pharmaceutical firm said the approval of the drug is based on Destiny-Lung02 trial results, in which the drug showed a 49% objective response rate and median duration of response of 16.8 months.
Astra said one complete response rate was observed, alongside 49 partial responses.
The approval is to treat patients with non-small cell lung cancer whose tumours have an activating HER2 mutation following chemotherapy.
Enhertu is being jointly developed alongside Daiichi Sankyo Co Ltd.
Astra said the approval also comes after a positive opinion of the drug was adopted by the Committee for Medicinal Products for Human Use.
Dave Fredrickson, executive vice president of oncology as AstraZeneca said: "Understanding the molecular drivers behind a lung cancer diagnosis is critical, and while there are now targeted options for many patients, those with HER2 mutant non-small cell lung cancer have had few treatment options, none of which have been approved to treat their specific type of lung cancer.
"Enhertu is the first HER2 directed option approved for HER2 mutant disease and confirms the relevance of HER2 as a target in lung cancer."
AstraZeneca shares were down 0.7% to 10,356.00 pence each on Monday morning in London.
By Harvey Dorset, Alliance News reporter
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