Erika Hamilton, Chief Development Officer, Late Phase and Director, Breast Cancer Research Program at Sarah Cannon Research Institute, shared on LinkedIn:
“SERENA-6 just got approval by FDA!
This isn’t ‘just’ a great new drug approval in breast cancer. Camizestrant is an oral SERD that now has approval in 1L (or maybe 1.5L if you want to call it that) breast cancer. It’s incredibly well tolerated and we’ve had the opportunity to treat many patients SCRI Oncology Partners, Sarah Cannon Research Institute on it since phase I.
But why this is so important in breast cancer, is that it shepherds in the beginning of a new paradigm. The ability to use molecular testing, the emergence of ESR1m during a patients treatment, to change their treatment in the absence of progression. What is really important here is the advance of progression part and is incredibly novel in breast cancer.
It’s been a controversial road and honestly all the questions still aren’t answered. But that’s not suprising as it often happens in cancer clinical trials….the data matures as we go.
Additionally, stay tuned for more camizestrant trials including SERNA-4 which will report soon for upfront cami with CDK in the 1st line as well as CAMBRA-1 and CAMBRIA-2 which tests cami in the adjuvant setting either up front or as a switch strategy for extended endocrine therapy.”
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