4 Topic Commentaries

FDA approves combo for ESR1-mutated breast cancer

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  Kyle Diamantas, J.D.

  Regulatory policy

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  U.S. Food and Drug Administration

  “Women living with metastatic breast cancer face an uphill battle as their tumors continuously evolve to escape treatment. We owe them every weapon in our arsenal.” “Today’s approval delivers a win to these patients by granting them a targeted therapy designed specifically to overcome resistance, giving them more time before their disease progresses.”

  Source
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  Angelo de Claro, M.D.

  Regulatory oncology

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  U.S. Food and Drug Administration

  “I commend both the FDA and the sponsor for their commitment to advancing cancer care and securing this accelerated approval,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence. “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 that the disease is progressing. But additional evidence is needed to confirm clinical benefit.”

  Source
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  Eleonora Teplinsky, MD

  Breast medical oncology

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  Valley-Mount Sinai Comprehensive Cancer Care

  “The early switch approach of the SERENA-6 clinical trial resulted in a 56% reduction in the risk of disease progression or death for patients who switched to treatment with camizestrant, allowing patients to stay on first-line therapy for a longer period of time. Camizestrant is not yet FDA approved, but this data will likely pave the way for a new treatment paradigm in first-line therapy for HR-positive, HER2-negative advanced breast cancer,”

  Source
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  Nicholas C. Turner, MD, PhD

  Medical oncology (breast cancer)

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  Royal Marsden Hospital, London, United Kingdom

  “Following progression of disease on first-line therapy for advanced HR-positive breast cancer, a number of treatment options exist. However, their benefit is limited; quality of life decreases, and survival rates are low. Patients have an urgent need for new treatments that can prolong time on first-line therapy and delay disease progression. The results from SERENA-6 represent an important step forward and a potential new treatment strategy to improve first-line outcomes for patients,”

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