In the phase III SERENA-6 study, the combination reduced the risk of disease progression or death by 56 percent compared with standard treatment.
“Today’s approval is the tenth that the FDA has granted to Astra Zeneca’s portfolio this year and the fourth in breast cancer alone. The Etcamah combination reflects Astra Zeneca’s leading role in redefining breast cancer treatment by paving the way for a new approach based on circulating tumor DNA. It is the first and only treatment of its kind for first-line treatment,” says Dave Fredrickson, head of the Oncology Haematology business area at Astra Zeneca.
Astra Zeneca receives US approval for Etcamah
The pharmaceutical company Astra Zeneca has received accelerated FDA approval for Etcamah in combination with a CDK4/6 inhibitor for advanced HR-positive, HER2-negative breast cancer with an ESR1 mutation.
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