AstraZeneca's Camizestrant Recommended for EU Approval in Advanced Breast Cancer

AstraZeneca PLC filed a Form 6-K announcing that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended approval of camizestrant in combination with CDK4/6 inhibitors for first-line treatment of adult patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with emergent ESR1 mutations. The positive opinion is based on results from the pivotal SERENA-6 Phase III trial, which showed the combination reduced the risk of disease progression or death by 56% compared to standard-of-care treatment. The trial demonstrated median progression-free survival of 16.0 months versus 9.2 months for the control group. If approved, camizestrant would be the first next-generation oral selective estrogen receptor degrader for use with CDK4/6 inhibitors in this setting. Regulatory applications are also under review in the US, Japan, and other countries.