Eisai Highlights New Research On Melanoma, Breast and Endometrial Cancer at ASCO Annual Meeting
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.
“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 Marker for Clinical Outcomes (E7080) Poster Discussion Session Abstract No: 5520 ----------------- Lenvatinib Analysis of Plasma Biomarker and Tumor Genetic Alterations from a Phase II Trial of Lenvatinib in Patients with Advanced Endometrial Cancer (E7080) Poster Presentation Abstract No: 5591 ----------------- 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 Advanced BRAF Wild- Type Melanoma (E7080) Poster Presentation Abstract No: 9058 ----------------- Lenvatinib Lenvatinib Combined with Dacarbazine versus Dacarbazine Alone as First- Line Treatment in Patients with Stage IV Melanoma (E7080) Poster Discussion Session Abstract No: 9027 ----------------- Eribulin Mesylate Quality of Life (QoL) in Patients (pts) with Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with Anthracyclines and Taxanes who Received Eribulin Mesylate or Capecitabine: a Phase III, Open- Label, Randomized Study Abstract No: 1050 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 (ER+) Early Stage Breast Cancer: Phase II, Multicenter, Single-Arm Study Abstract No: 563 Poster Presentation --- Eribulin Mesylate A Phase III, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer (MBC) Previously Treated with Anthracyclines and Taxanes: Subgroup Analyses Abstract No: 1049 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.
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)
- Your 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.
- If 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.
- Neutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever.
- Neutropenia 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 100.5F), chills, coughing, and burning or pain when you urinate.
Peripheral Neuropathy (Nerve Problems)
- Halaven 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.
- Severe 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.
- Peripheral neuropathy was the most common side effect that caused patients to stop taking Halaven.
Pregnancy and Nursing
- Halaven 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.
- It 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)
- Halaven can cause changes in your heartbeat. This can cause irregular heartbeats that may lead to death.
- Before you receive Halaven, tell your healthcare provider if you have heart problems, including a problem called “congenital long QT syndrome.”
- Your 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
- Before 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
- The 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.
- The 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 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.
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 products across 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.
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