Herceptin is a targeted therapeutic antibody treatment for HER2-positive breast cancer. HER2-positive breast cancer is an aggressive form of the disease that affects approximately one-fourth of women with breast cancer. Herceptin works by binding to the HER2 receptor on cancer cells, inhibiting their growth and survival. It is the only targeted biologic therapy approved for the treatment of HER2-positive breast cancer in both adjuvant (early) and metastatic (advanced) settings. Since its initial FDA approval in 1998, Herceptin has significantly improved survival rates for patients with HER2-positive breast cancer.
Breast cancer is a malignant tumor that originates in the cells of the breast, commonly affecting the ducts and lobules. It is the most common cancer among women worldwide, though it can also occur in men. The development of breast cancer involves the abnormal growth of breast cells that can invade surrounding tissues and spread to other parts of the body (metastasize). Risk factors include genetic mutations (such as BRCA1 and BRCA2), family history of breast cancer, hormonal influences, and certain lifestyle factors such as alcohol consumption and obesity.
Early detection through screening methods like mammography, breast self-examinations, and clinical breast exams is crucial for effective treatment and improved survival rates. Treatment options vary based on the stage and subtype of breast cancer and may include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Advancements in personalized medicine and ongoing research continue to enhance the understanding and management of breast cancer, leading to more tailored and effective treatment approaches.
Companion diagnostic testing is critical in determining the suitability of HERCEPTIN (trastuzumab) for treating breast cancer patients. HERCEPTIN targets the human epidermal growth factor receptor 2 (HER2), which is overexpressed in some breast cancers. Companion diagnostic tests, such as immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), are used to measure HER2 protein levels or gene amplification in tumor tissue samples. These tests identify patients with HER2-positive tumors who are likely to benefit from HERCEPTIN therapy. By ensuring that only patients with HER2-positive breast cancer receive HERCEPTIN, these diagnostic tests optimize treatment efficacy and minimize unnecessary exposure to the drug, which is crucial given its specific mechanism of action and potential side effects.
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This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
HERCEPTIN (trastuzumab) is a targeted therapy used to treat HER2-positive breast cancer. It is effective in both early-stage (adjuvant) and metastatic (advanced) settings. HERCEPTIN works by binding to the HER2 protein on cancer cells, inhibiting their growth and survival. It is also used to treat HER2-positive metastatic stomach cancer.
HERCEPTIN targets the HER2 protein, which is overexpressed in certain types of breast cancer cells. By binding to the HER2 receptors, HERCEPTIN blocks the growth signals, prevents the proliferation of cancer cells, and marks them for destruction by the immune system.
Patients with HER2-positive breast cancer are eligible for HERCEPTIN treatment. Eligibility is confirmed through companion diagnostic tests like immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), which detect HER2 overexpression or gene amplification in tumor tissue samples.
Common side effects of HERCEPTIN include fever, nausea, vomiting, diarrhea, infections, increased cough, headache, fatigue, and rash. Serious side effects can include heart problems, lung problems, and severe infusion reactions. Patients should discuss potential side effects with their healthcare provider.
HERCEPTIN is administered as an intravenous (IV) infusion. The dosage and schedule depend on the specific condition being treated and the patient’s response to therapy. It is often given in combination with chemotherapy drugs for a more effective treatment regimen.
Companion diagnostic tests are essential for identifying patients who will benefit from HERCEPTIN. These tests determine the HER2 status of the tumor, ensuring that only patients with HER2-positive cancers receive the treatment. This targeted approach maximizes the efficacy of HERCEPTIN and reduces the risk of unnecessary side effects for patients with HER2-negative tumors.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
