AstraZeneca’s breast cancer pill wins US approval in accelerated process

The FDA approved AstraZeneca's camizestrant (Etcamah) for advanced breast cancer, triggered by a blood test detecting ESR1 mutations. The drug, used with CDK4/6 inhibitors, showed 16-month median progression-free survival in trials. The approval is conditional, pending confirmatory studies on overall survival benefits. The FDA also authorized the Guardant360 CDx test for detecting ESR1 mutations. The drug carries warnings for heart rhythm issues and fetal harm.

AstraZeneca's breast cancer drug, camizestrant (brand name Etcamah), received FDA approval for use in metastatic breast cancer patients with a specific genetic mutation. The drug is expected to generate over $5 billion in annual sales, according to the company, but analysts predict lower figures. The FDA's approval follows an earlier advisory panel vote against the medicine.

AstraZeneca's ETCAMAH (camizestrant) in combination with a CDK4/6 inhibitor has been approved in the U.S. for 1st-line advanced HR-positive breast cancer. The approval follows Phase III trial results showing a 56% reduction in disease progression or death risk for patients with an ESR1 tumor mutation, according to the company.

AstraZeneca's ETCAMAH® (camizestrant) in combination with a CDK4/6 inhibitor received FDA approval for 1st-line advanced HR-positive breast cancer. The approval was based on the SERENA-6 Phase III trial, which showed a 56% reduction in the risk of disease progression or death. The treatment is the first of its type in the 1st-line setting and has the potential to reshape treatment paradigms for this form of advanced breast cancer. AstraZeneca has received its tenth FDA approval this year, with f

Guardant Health (GH) received FDA approval for Guardant360 CDx as a companion diagnostic for AstraZeneca's ETCAMAH in advanced breast cancer. The approval, based on the SERENA-6 trial, showed a 56% reduction in disease progression risk when using ctDNA-guided treatment. The test is recommended for use every three months during therapy.

The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant) for treating advanced breast cancer with ESR1 mutations. The approval was based on a clinical trial showing 16-month median progression-free survival. The FDA required confirmatory studies to verify clinical benefit. The approval includes a companion diagnostic test, Guardant360 CDx, for identifying eligible patients.