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FDA OKs Targeted Therapy for Evolving Breast Cancer
5 Sep
Summary
- FDA approved a new breast cancer drug, camizestrant, for resistant cases.
- The drug targets ESR1 mutations causing acquired tumor resistance.
- This is the first FDA approval guided by ctDNA resistance mutation detection.
The Food and Drug Administration announced on Friday the accelerated approval of camizestrant, a novel targeted therapy designed for patients with metastatic breast cancer who have developed resistance to hormone therapy. This drug specifically addresses ESR1 mutations, which are acquired changes that tumors can develop during treatment.
Acting FDA Commissioner Kyle Diamantas emphasized the critical need for new weapons against evolving cancer. He stated that this approval provides patients with a targeted therapy aimed at overcoming resistance, thereby extending the time before their disease progresses.
Dr. Angelo de Claro highlighted that this approval is groundbreaking. It is the first FDA clearance of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) prior to visible disease progression on imaging tests. However, he noted that further evidence is required to fully confirm its clinical benefits.
