(Reuters) – The European Union’s health regulator on Friday backed AstraZeneca and Daiichi Sankyo’s drug Enhertu as a breast cancer treatment for patients who received endocrine therapy but are not suitable for additional hormone treatments.
The recommendation is based on a late-stage study that showed participants given Enhertu lived for a median of 13.2 months before their cancer worsened, compared with 8.1 months for those given chemotherapy.
“Endocrine therapy is typically used in the initial treatment of HR-positive metastatic breast cancer but as the disease progresses, the benefit of continued endocrine therapy is limited, and subsequent standard-of-care chemotherapy is associated with poor outcomes,” said Susan Galbraith, executive vice president of oncology R&D, at AstraZeneca.
In November, the National Institute for Health and Care Excellence — which decides what drugs are available on Britain’s National Health Service — said it had not reached a cost-effective pricing agreement with AstraZeneca and Japan’s Daiichi, maintaining its decision not to recommend Enhertu for advanced breast cancer.
Enhertu is currently approved in more than 75 countries.
(Reporting by Raechel Thankam Job; Editing by Shilpi Majumdar)
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