AstraZeneca Gets FDA Approval for Breast Cancer Treatment

By Elias Schisgall


The Food and Drug Administration approved an AstraZeneca-made treatment for advanced breast cancer.

The agency on Friday said it granted accelerated approval for AstraZeneca's Etcamah drug, known generically as camizestrant, in combination with a CDK4/6 inhibitor to treat eligible breast cancer patients.

The approval applies to adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer, after detection of an estrogen receptor-1 mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy.

The FDA also approved a companion diagnostic test to detect emerging ESR1 resistance mutations, the company said.

"The Etcamah combination reflects AstraZeneca's leadership in redefining breast cancer care by pioneering a new approach using circulating tumour DNA and is the first and only medicine of its type in the 1st-line setting," AstraZeneca's executive vice president of the oncology haematology business unit, Dave Fredrickson said.


Write to Elias Schisgall at elias.schisgall@wsj.com


(END) Dow Jones Newswires

September 04, 2026 18:22 ET (22:22 GMT)

Copyright (c) 2026 Dow Jones & Company, Inc.

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