LONDON (dpa-AFX) - AstraZeneca PLC (AZN) on Tuesday said the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of camizestrant in combination with a CDK4/6 inhibitor for the treatment of adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with ESR1 mutation.
The positive opinion was based on results from the Phase III SERENA-6 trial, where the camizestrant combination reduced the risk of disease progression or death by 56% compared with standard-of-care. Median progression-free survival was 16.0 months for the camizestrant combination versus 9.2 months for standard treatment.
Camizestrant is already approved in the United Arab Emirates and Saudi Arabia for certain patients with HR-positive, HER2-negative advanced breast cancer with ESR1 mutations.
Regulatory applications for the therapy in this setting are also under review in the U.S., Japan and several other countries.
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