FDA Approves Etcamah Combination for Advanced Breast Cancer

What Is Etcamah, and How Does It Work?

The FDA has approved Etcamah (camizestrant) to treat adults with advanced breast cancer.

It is used for tumors that are hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative.

This medicine is for patients whose cancer has an abnormal gene change called an ESR1 mutation.

It is taken together with another cancer medicine called a CDK4/6 inhibitor. In HR-positive breast cancer, the hormone estrogen helps cancer cells grow. A common treatment is an aromatase inhibitor, which lowers estrogen levels in the body. Over time, cancer cells can change and develop an ESR1 mutation. This gene change allows the tumor to grow even without much estrogen. Etcamah works by blocking and breaking down estrogen receptors. This helps stop the mutated cancer cells from growing.

Why Was Etcamah Approved?

The FDA approved Etcamah based on a clinical study called SERENA-6. The study included 315 adult patients with advanced breast cancer that had an ESR1 mutation. Patients were tested every two to three months using a blood test to catch the gene change early. The study compared patients who switched to Etcamah plus a CDK4/6 inhibitor against patients who stayed on an aromatase inhibitor plus a CDK4/6 inhibitor. In the study, patients who took Etcamah lived a median of 16 months without their cancer getting worse. Patients who stayed on standard therapy lived a median of 9.2 months without disease progression. Common side effects in the study included low blood cell counts, vision changes, and feeling tired. Because approval was granted based on how long patients lived without disease progression, more studies are needed to confirm the long-term benefits.

What Do I Need to Know About Etcamah?

Etcamah is a tablet that you swallow whole once a day with or without food. You should take it about the same time every day. You will continue taking your assigned CDK4/6 inhibitor as directed by your healthcare provider. Etcamah can cause serious heart risks. It can cause a slow heart rate or changes in the electrical activity of your heart called QTc prolongation. Taking Etcamah with certain other drugs, like ribociclib, can raise the risk of severe heart rhythm issues. Your healthcare provider will check your heart rate and do heart tests called electrocardiograms (EKGs) before and during treatment. Get emergency medical help right away if you feel dizzy, lightheaded, faint, or feel your heart racing.

The most common side effects of Etcamah include low white blood cells, low red blood cells, low blood platelets, tiredness, and vision problems. Vision changes can include seeing flashes of light, blurred vision, or new floaters. Tell your healthcare provider if you have any vision changes.Etcamah can harm a fetus. You should not take this medicine if you are pregnant or breastfeeding. Females who can get pregnant should use effective non-hormonal birth control during treatment and for a month after the last dose. Males with female partners who can get pregnant should use effective birth control during treatment and for a week after the last dose. Tell your healthcare provider about all medicines, over-the-counter drugs, and vitamins you take.

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