Recently, the U.S. Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca's Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer.
The applicable precondition is: patients have ESR1 mutations detected by an FDA-authorized test while receiving an aromatase inhibitor (AI) and a CDK4/6 inhibitor.
Safety Profile
This accelerated approval is mainly based on the pivotal results of the phase 3 SERENA-6 trial, which were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.
In the SERENA-6 trial, the safety of Etcamah combined with palbociclib, ribociclib, or abemaciclib was consistent with the known profiles of each drug, no new safety signals were identified, and discontinuation rates were low and similar in both groups.
Global Approval and Research and Development Landscape of Etcamah
Etcamah (camizestrant) is a potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist, administered orally once daily at a recommended dose of 75 mg (when combined with a CDK4/6 inhibitor).
Based on the SERENA-6 results, Etcamah in combination with a CDK4/6 inhibitor has been approved in the United States, the European Union, Japan, Canada, the United Kingdom, and more than 30 countries worldwide for the same indication as above.
AstraZeneca is also advancing multiple phase 3 trials of Etcamah (SERENA-4, CAMBRIA-1, CAMBRIA-2), evaluating its efficacy and safety as monotherapy or in combination with a CDK4/6 inhibitor in different settings of HR-positive/HER2-negative breast cancer.
Clinical Significance and Expert Perspectives
Kevin Kalinsky, MD, MS, FASCO (Director of Medical Oncology at Winship Cancer Institute of Emory University and trial investigator), said: "About one-third of these patients with advanced breast cancer will develop ESR1 mutations before radiographic or clinical progression, and this combination provides an important new option for this patient population. Today's approval enables clinicians to intervene earlier and adjust treatment strategy before disease progression, rather than waiting until the cancer is more difficult to treat and the patient's prognosis and quality of life have worsened."
Dave Fredrickson (Executive Vice President of AstraZeneca's Oncology Hematology Business Unit) said: "This approval is AstraZeneca's tenth FDA approval this year, and the fourth in breast cancer alone. The Etcamah combination pioneers a new model of using circulating tumor DNA (ctDNA) to guide treatment, reflecting AstraZeneca's leadership in redefining breast cancer treatment, and is the first and only drug in its class for first-line treatment."
