FDA ODAC didn’t reach a majority vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR+ve HER2neg breast cancer
Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “New innovations and novel treatment strategies that provide benefit to patients are required to drive advances in this 1st-line setting, and so we are disappointed with the mixed outcome of today’s ODAC meeting. We strongly believe in the results of the SERENA-6 trial, and are encouraged that the Committee saw camizestrant as a safe and effective potential new medicine. We remain confident in the clinical benefit the combination can bring to patients by changing therapeutic strategy at the earliest opportunity, and are committed to challenging the status quo in the pursuit of innovation that optimises outcomes for patients.”
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