Kamel Abou Hussein, Director of Breast Medical Oncology at MD Anderson Cancer Center at Cooper, shared a post by FDA on LinkedIn, adding:
“So glad to see the accelerated approval (confirmatory trials required!) of camizestrant based on the results of the landmark SERENA-6 trial.
SERENA-6 represents an important step forward in how we think about endocrine resistance in HR-positive/HER2-negative advanced breast cancer; not simply waiting for radiographic progression, but using ctDNA to detect an emerging ESR1 mutation and intervene earlier.
The trial demonstrated a clinically meaningful improvement in progression-free survival with a strategy of switching to camizestrant while continuing CDK4/6 inhibition, reinforcing the potential of molecular monitoring to guide treatment before overt disease progression.
This is more than another endocrine therapy approval. It is a meaningful step toward a more dynamic, biomarker-driven approach to metastatic breast cancer care.
Congratulations to everyone who contributed to the SERENA-6 study and to the patients who made this progress possible. An exciting moment for our field!”
Quoting FDA :
“FDA expands treatment options for women with advanced breast cancer!
The FDA granted accelerated approval to Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who develop an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy.
This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show disease progression – reflecting FDA’s commitment to advancing medical innovation and getting new treatments to patients faster.”
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