AstraZeneca: Enhertu approval extended in US
(CercleFinance.com) - AstraZeneca announced on Monday that it has won approval from the US FDA to market its Enhertu immunotherapy for the treatment of metastatic breast cancer known as "weak HER2".
The antibody - developed and marketed with Japan's Daiichi Sankyo - is now approved in the US for the treatment of adult patients with non-operable or metastatic breast cancer that under-expresses the HER2 gene.
This approval is for individuals who have received prior chemotherapy or have experienced disease relapse within six months of completing treatment.
Enhertu - a conjugate that targets HER2 receptors - is already approved in about 30 countries for the treatment of adult patients with HER2-positive breast cancer.
The drug is also approved in some countries for the treatment of certain gastric cancers that also express the HER2 gene.
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