FDA Grants Approval For New Treatment For Metastatic HER-2 Breast Cancer

FDA Grants Approval For New Treatment For Metastatic HER-2 Breast Cancer

Drug Regulatory Authority in the US has approved a new treatment called Enhertu for patients who are living with unresectable HER2 positive breast cancer. The treatment can be given to those patients who have taken at least two or more anti-HER2 based regimens. Unresectable or metastatic HER2 positive breast cancer cannot be removed through surgery. In this case, cancer cells spread to other body parts of the patient. Enhertu is a form of human epidermal growth factor receptor 2 (HER2) antibodies that target changes in HER2 that accelerate cancer growth. The new drug is linked to topoisomerise inhibitors. This inhibitor is a toxic chemical compound for cancer cells. There have been many drug inventions for HER2- positive breast cancer since the inception of Herceptin (trastuzumab) in 1998.

Dr. Richard Pazdur, the director of the FDA’s Oncology Center of Excellence has said that drug inventions in the field of targeted therapies create an understanding of malignant diseases in multiple other diseases. As per the data, one out of five breast cancer cases generates gene mutation in the cancer cells, which develops an excess of the HER2 protein. HER2- breast cancers are violent types of breast cancer. The approval of Enhertu is based on the findings of clinical trials conducted on 184 women with metastatic breast cancer, who have undergone two or more anti-HER2 remedies in the metastatic setting. They were heavily treated in the metastatic setting before getting Enhertu. Patients in the clinical trial of Enhertu got the drug every three weeks. The scan of the tumor as well was taken after every six weeks.  The general response rate of the trial was around 60.3 percent. The response rate showed the tumor reduction of patients with a median duration of the reaction of 14.8 months.

Researchers have mentioned a couple of warnings as well in the prescribing information of Enhertu. As per the experts, the drug can cause certain lung disease and embryo-fetal toxicity. The warning with the new drug says that it can cause interstitial lung disease and pneumonitis, which can result in death also. Scientists have said that doctors need to monitor signs such as coughing, fever, dyspnea, and other difficult respiratory symptoms. If these symptoms show up, the treatment of Enhertu needs to be stopped, said the officials. Doctors need to inform their patients to use effective contraception during the treatment. Pregnant women are not allowed to take Enhertu treatment, as it will harm the developing fetus or newborn baby. Nausea, fatigue, hair loss, constipation, vomiting, anemia, and low appetite are common symptoms of the new drug.

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