FDA Grants Accelerated Approval to AstraZeneca's Breast Cancer Pill Etcamah for ESR1-Mutated Tumors

The U.S. Food and Drug Administration has granted accelerated approval to AstraZeneca's camizestrant, branded as Etcamah, for the treatment of hormone receptor-positive, HER2-negative advanced or metastatic breast cancer in patients whose tumors carry ESR1 mutations, specifically before radiographic disease progression. Etcamah is a next-generation oral selective estrogen receptor degrader and complete ER antagonist, taken once daily, and represents a significant addition to AstraZeneca's oncology pipeline.

Alongside the drug approval, the FDA approved Guardant Health's Guardant360 CDx liquid biopsy test as the companion diagnostic to identify patients with ESR1 mutations who may benefit from Etcamah. Guardant Health, based in Palo Alto and listed on Nasdaq under the ticker GH, said the approval marks a landmark for its precision oncology platform.

The FDA decision follows a more complex regulatory path for AstraZeneca's broader camizestrant program. In April 2026, an FDA advisory committee voted 3 to 6 against recommending approval of camizestrant in combination with CDK4/6 inhibitors for first-line HR-positive breast cancer, and in May 2026 the FDA extended its review timeline for that combination application. The European Union separately approved Etcamah in combination with CDK4/6 inhibitors in July 2026, based on Phase III SERENA-6 trial data showing the combination reduced the risk of disease progression or death by 56% compared with standard therapy.