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AstraZeneca Wins FDA Accelerated Approval for Breast Cancer Drug Etcamah

AstraZeneca Wins FDA Accelerated Approval for Breast Cancer Drug Etcamah

MT newswireMT newswire2026/09/04 22:25
06:25 PM EDT, 09/04/2026 (MT Newswires) -- Astrazeneca (AZN) said Friday the FDA granted accelerated approval to its drug Etcamah, camizestrant, for adults with a common type of advanced or metastatic breast cancer. The drug is used together with another cancer drug called a CDK4/6 inhibitor. The approval is for patients whose tumors develop a specific gene change, called an ESR1 mutation, that lets the cancer resist standard hormone therapy over time, according to the release. The FDA said this is the first cancer drug approval based on finding this resistance mutation through a blood test, before scans show the cancer is getting worse. The agency also approved a blood test called Guardant360 CDx to identify patients who qualify for the treatment. In the study behind the approval, patients who switched to Etcamah lived a median of 16 months without their cancer worsening, compared with 9.2 months for those who stayed on their original hormone therapy, according to the FDA.
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