Eisai Highlights New Research On Melanoma, Breast and Endometrial Cancer at ASCO Annual Meeting PR Newswire WOODCLIFF LAKE, N.J., May 16, 2013 WOODCLIFF LAKE, N.J., May 16, 2013 /PRNewswire/ -- Eisai Inc. announced today that nine abstracts highlighting new study results in melanoma, breast and endometrial cancer will be presented during the 49^th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago from May 31 - June 4, 2013. (Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO ) "These studies reinforce Eisai's strong and growing commitment to oncology, particularly to cancers affecting women," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai Inc. "Eisai's portfolio of oncology compounds and products are further testament to our human health care (hhc) mission of keeping the unmet needs of patients with cancer and their families at the forefront of all that we do." The following Eisai abstracts are accepted for presentation at this year's ASCO meeting: Product Abstract Name Lenvatinib A Phase II Trial of Lenvatinib in Patients with Advanced or Recurrent Endometrial Cancer: Angiopoietin-2 as a Predictive (E7080) Marker for Clinical Outcomes Abstract No: 5520 Poster Discussion Session Lenvatinib Analysis of Plasma Biomarker and Tumor Genetic Alterations from a Phase II Trial of Lenvatinib in Patients with (E7080) Advanced Endometrial Cancer Abstract No: 5591 Poster Presentation Lenvatinib A Phase II Study of the Multi-targeted Kinase Inhibitor Lenvatinib in Patients with Advanced BRAF Wild-Type Melanoma (E7080) Poster Discussion Session Abstract No: 9026 Lenvatinib Analysis of Serum Biomarkers and Tumor Genetic Alterations from a Phase II Study of Lenvatinib in Patients with (E7080) Advanced BRAF Wild-Type Melanoma Abstract No: 9058 Poster Presentation Lenvatinib Lenvatinib Combined with Dacarbazine versus Dacarbazine Alone as First-Line Treatment in Patients with Stage IV (E7080) Melanoma Abstract No: 9027 Poster Discussion Session Quality of Life (QoL) in Patients (pts) with Locally Advanced or Metastatic Breast Cancer (MBC) Previously Eribulin Mesylate Treated with Anthracyclines and Taxanes who Received Eribulin Mesylate or Capecitabine: a Phase III, Open-Label, Abstract No: 1050 Randomized Study Poster Presentation Eribulin Mesylate Quality of Life (QoL) and Content Validity in Objective Tumor Response Abstract No: 1055 Poster Presentation Eribulin Mesylate Eribulin Mesylate (Erib) Plus Capecitabine (X) for Adjuvant Treatment in Post-Menopausal Estrogen Receptor-Positive Abstract No: 563 (ER+) Early Stage Breast Cancer: Phase II, Multicenter, Single-Arm Study Poster Presentation A Phase III, Open-Label, Randomized Study of Eribulin Eribulin Mesylate Mesylate Versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer (MBC) Previously Abstract No: 1049 Treated with Anthracyclines and Taxanes: Subgroup Analyses Poster Presentation The information discussed in this release presents investigational agents that are not Food and Drug Administration (FDA)-approved and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any of these agents will successfully complete clinical development or gain FDA approval. About Lenvatinib Lenvatinib is an investigational small molecule tyrosine kinase inhibitor being studied by Eisai as an oral agent in a wide array of tumor types. HALAVEN® (eribulin mesylate) Injection Halaven is a prescription medicine used to treat patients with metastatic breast cancer. Halaven is for patients who have already received at least two other types of anticancer medicines for their breast cancer once it has spread to other parts of the body. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer. Important Safety Information about HALAVEN® Neutropenia (Decreased White Blood Cells) oYour doctor should do a blood test to monitor your blood cells before you receive each dose of Halaven, and should monitor you more often if you develop lower white blood cells. oIf you develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, your next dose of Halaven should be delayed and reduced. In a clinical trial, severe neutropenia occurred in 57% of patients who received Halaven and lasted more than 1 week in 12% of patients. oNeutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever. oNeutropenia with a fever can result in serious infections that could lead to hospitalization or death. Call your health care provider immediately if you have any of the following symptoms: fever (temperature above 100.5˚F), chills, coughing, and burning or pain when you urinate. Peripheral Neuropathy (Nerve Problems) oHalaven can cause numbness, tingling, or burning in your hands and feet (peripheral neuropathy). You should be monitored closely for signs of neuropathy. If you develop severe neuropathy, treatment with Halaven should be delayed until the neuropathy improves and the next dose of Halaven should be reduced. oSevere peripheral neuropathy occurred in 8% of patients who received Halaven. Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days. oPeripheral neuropathy was the most common side effect that caused patients to stop taking Halaven. Pregnancy and Nursing oHalaven may harm your unborn baby. Avoid becoming pregnant while you are receiving Halaven. Tell your health care provider right away if you become pregnant or think you are pregnant while you are receiving Halaven. oIt is not known if Halaven passes into your breast milk. You and your health care provider should decide if you will take Halaven or breast-feed. You should not do both. QT Prolongation (Heartbeat Changes) oHalaven can cause changes in your heartbeat. This can cause irregular heartbeats that may lead to death. oBefore you receive Halaven, tell your healthcare provider if you have heart problems, including a problem called "congenital long QT syndrome." oYour health care provider will decide if you need heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with Halaven to watch for this problem. Pre-existing Liver and/or Kidney Problems oBefore you receive Halaven, tell your healthcare provider if you have liver or kidney problems. A lower starting dose of Halaven is recommended in patients with mild or moderate liver problems, and/or moderate kidney problems. Most Common Side Effects oThe most common side effects reported in greater than or equal to 25% of patients receiving Halaven were low white blood cells; low red blood cells; weakness/tiredness; hair loss; numbness, tingling, or burning in the hands and feet; nausea; and constipation. oThe most common serious side effects reported in patients receiving Halaven were neutropenia with or without a fever. For full prescribing information for HALAVEN, please visit: http://www.halaven.com/sites/default/files/HALAVEN_full_Prescribing_Information.pdf Eisai Oncology Eisai Oncology is dedicated to discovering, developing and producing innovative oncology therapies that may make a difference and impact the lives of patients and their families. This passion for people is part of Eisai's human health care (hhc) mission, which strives for better understanding of the needs of patients and their families to increase the benefits health care provides. Our commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, vaccines, and biologic agents across various types of cancer. For more information about Eisai, please visit www.eisai.com/US. Eisai Inc. At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., our passionate commitment to patient care is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US. Eisai Co., Ltd. Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets productsacross the world through a global network of research facilities, manufacturing sites and marketing subsidiaries.For more information about Eisai's global operations,please visit www.eisai.com. Contact: Media Investors Laurie Landau Alex Scott Eisai Inc. Eisai Inc. 201-746-2510 201-746-2177 SOURCE Eisai Inc. Website: http://www.eisai.com
Eisai Highlights New Research On Melanoma, Breast and Endometrial Cancer at ASCO Annual Meeting
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