FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “We are committed to continuously advancing the clinical landscape in oncology in pursuit of improving outcomes for patients. The SERENA-6 treatment strategy epitomises this approach by monitoring patients for the emergence of ESR1 mutations in ctDNA and testing if a switch of endocrine backbone therapy at this point improves outcomes. We look forward to continuing the dialogue with the FDA in order to bring the benefits of camizestrant with this innovative treatment strategy to eligible patients in the US as quickly as possible.”
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