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Ekalia plans to install its first astatine-211 production unit at Telix’s RLS Radiopharmacies site in Trevose, Pennsylvania.
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The accelerated approval was based on results from AstraZeneca’s pivotal SERENA-6 Phase III trial, which showed Etcamah in combination with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% in advanced HR-positive breast cancer patients with an emergent ESR1 tumour mutation.
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