The first breast cancer therapy for specific genetic mutations was approved today
January 15, 2018 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Just after the JP Morgan Healthcare Conference, the industry has ushered in a good news. AstraZeneca and Merck (MSD) today announced that the US FDA has expanded the use of Lynparza (olaparib) to treat patients with or suspected to have a germline BRCA mutation (gBRCAm) and a negative human epidermal growth factor receptor 2 (HER2). And patients with metastatic breast cancer who have received chemotherapy who have received chemotherapy. If the patient's hormone receptor (HR) is positive, it should be treated with endocrine therapy beforehand, or considered to be unsuitable for endocrine therapy.
It is worth mentioning that this is the first PARP inhibitor approved for the treatment of breast cancer, and the first drug approved for the treatment of patients with metastatic breast cancer with BRCA mutation.
Breast cancer is the most common form of cancer in the United States. According to estimates by the National Cancer Institute (NCI), about 252,710 women were diagnosed with breast cancer this year, and 40,610 of them will die of the disease. Approximately 20%-25% of hereditary breast cancer patients and 5%-10% of any type of breast cancer patients have BRCA mutations. The BRCA gene is involved in repairing damaged DNA and preventing tumor progression. However, mutations in these genes may lead to certain cancers, including breast cancer. These patients need a targeted drug.
Lynparza is such a drug. As a PARP (poly ADP-ribose polymerase) inhibitor, it can further block the PARP enzyme involved in repairing damaged DNA, making DNA mutations in cancer cells with damaged BRCA gene difficult to return, leading to cell death. Slow or prevent tumor growth. Lynparza was first approved by the FDA for the treatment of certain ovarian cancer patients in 2014.
â–²Olaparib's molecular structure (Source: Wikipedia)
The safety and efficacy of Lynparza for the treatment of breast cancer was demonstrated in randomized clinical trials involving 302 HER2-negative metastatic breast cancer patients with gBRCAm. This trial measures the time during which there is no significant increase in tumor after treatment (no progression survival, PFS). The median PFS was 7 months in the Lynparza group and 4.2 months in the chemotherapy group. The risk of disease progression or death was reduced by 42% (HR = 0.58; 95% CI: 0.43-0.80; P = 0.0009). The objective response rate was 52% (95% CI: 44-60) in the Lynparza group, which was twice (23%) (95% CI: 13-35) in the chemotherapy group. In addition, the complete response rate was 7.8% in the Lynparza group and 1.5% in the chemotherapy group.
"These drugs have been used to treat advanced ovarian cancer with BRCA mutations and now show the efficacy of breast cancer for certain types of BRCA mutations," said Acting Director, Office of Hematology and Oncology Products, FDA Center for Drug Evaluation and Research. Dr. Richard Pazdur, Director of the FDA Center for Excellence in Cancer, said: "This approval demonstrates the current development of examples of drugs that target the underlying genetic causes of cancer, which often span multiple cancer types."
â–²Dr. Richard Pazdur believes that the approval of this new drug is typical of the development of new drugs for precision tumors (Source: FDA)
Dr. Roy Baynes, Chief Medical Officer, Senior Vice President and Head of Global Clinical Development at Merck Research Laboratories, said: "This expanded approval of Lynparza represents an important advancement in patients with metastatic breast cancer with BRCA mutations and HER2 negative. In addition, this approval further drives our important collaboration with AstraZeneca in the development of cancer treatment."
Dr. Susan M. Domchek, executive director of the BRCA Basser Research Center at the University of Pennsylvania's Abramson Cancer Center and leader of the OlympiAD trial, said: "Patients diagnosed with BRCA mutation-related metastatic breast cancer are usually younger than other breast cancer patients and their disease It is usually more aggressive and more refractory. Although there is currently no cure for metastatic breast cancer, today's approval provides a new and targeted option that may help delay the progression of these patients."
We look forward to the approval of Lynparza's expanded indications to help more women with breast cancer.
Reference materials:
[FDA] FDA approves first treatment for breast cancer with a certain inherited genetic mutation
[2] LYNPARZA® (olaparib) Approved by US FDA in Germline BRCA-Mutated Metastatic Breast Cancer
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