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.