AstraZenca’s Etcamah combination therapy has been given FDA Accelerated Approval. The approval is for Etcamah (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) to treat adult patients with breast cancer.
The treatment is specifically for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of oestrogen receptor-1 (ESR1) mutation during aromatase inhibitor and CDK 4/6 inhibitor therapy.
In a planned interim analysis of the SERENA-6 phase 3 trial, Etcamah in combination with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus standard-of-care treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor.
ESR1 mutations are acquired resistance mutations that a tumour may develop during treatment with an aromatase inhibitor, a type of endocrine therapy that is a common front-line treatment for locally advanced or metastatic breast cancer. At the diagnosis of HR-positive metastatic breast cancer, fewer than 5% of patients will have this tumour mutation. After disease progression on an aromatase inhibitor, nearly 40% of patients will have this tumour mutation.
Kevin Kalinsky, Division Director of Medical Oncology, Winship Cancer Institute of Emory University and investigator for the trial, said: “This combination provides an important new option for the one in three patients with this form of advanced breast cancer whose tumours develop ESR1 mutations before clinical or radiographic disease progression.
“This approval will enable clinicians to promptly intervene and change therapeutic strategy at an earlier opportunity ahead of disease progression, rather than waiting until the cancer becomes harder to treat, and patient outcomes and quality of life worsen.”
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million patients were diagnosed with breast cancer in 2024, with more than 690,000 deaths globally. While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live for five years following diagnosis.
In the US, breast cancer is the most common cancer in women, with more than 300,000 new patients diagnosed annually, and more than 42,000 deaths.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The Etcamah combination [is] a new approach using circulating tumour DNA and is the first and only medicine of its type in the first-line setting.”
Approximately 37,000 patients with HR-positive metastatic breast cancer in the US are treated with a medicine in the first-line setting, most frequently with endocrine therapies that target oestrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors. However, resistance to these therapies frequently develop in many patients. Once this occurs, treatment options are limited and survival rates are low with just over a third of patients anticipated to live beyond five years after diagnosis.