WOODCLIFF LAKE, N.J., Nov. 28, 2012 /PRNewswire/ -- Eisai Inc. announced today that six abstracts highlighting new study results will be presented during the 2012 CTRC-AACR San Antonio Breast Cancer Symposium. The meeting will be held December 4-8, 2012 at the Henry B. Gonzalez Convention Center in San Antonio, TX.(Logo: http://photos.prnewswire.com/prnh/20120413/MM87168LOGO )
These studies highlight Eisai's current and ongoing clinical research efforts with Halaven® (eribulin mesylate) Injection, reinforcing the company's commitment to the breast cancer community. Additionally, Phase III study results of the head-to-head study of eribulin vs. capecitabine will be highlighted as part of a SABCS-sponsored news conference to be held on December 7, 2012.
"As part of our human health care mission we strive to better understand the needs of patients and their families to help increase the benefits that healthcare provides," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai. "Our continued work to further understand the clinical profile of eribulin underscores our commitment to this important mission."
The following Eisai abstracts are accepted for presentation at this year's San Antonio Breast Cancer Symposium:ProductAbstract NameEribulin Mesylate
S6-6A Phase III, open-label, randomized, multicenter study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with anthracyclines and taxanes
Oral PresentationEribulin Mesylate
P1-12-02Results of a Phase II, multicenter, single-arm study of eribulin mesylate as first-line therapy for locally recurrent or metastatic HER2-negative breast cancer
Poster SessionEribulin Mesylate
P5-20-04Eribulin mesylate + trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer: results from a Phase II, multicenter, single-arm study
Poster SessionEribulin Mesylate
P1-13-11Adjuvant treatment of early-stage breast cancer with eribulin mesylate following dose-dense doxorubicin and cyclophosphamide: preliminary results from a Phase II, single-arm feasibility study Poster SessionEribulin Mesylate
P6-11-14Post-hoc safety and tolerability assessment in patients receiving palliative radiation during treatment with eribulin mesylate for metastatic breast cancer
P6-09-06Family Members' Burden in Patients with Metastatic and Early Stage Breast Cancer
Poster SessionThe information discussed in this release is about investigational uses for an FDA-approved product. It is not intended to convey conclusions of efficacy and safety.
Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane either in the adjuvant or metastatic setting.
Important Safety Information about HalavenDecreased White Blood Cells (Neutropenia)
A doctor should do a blood test to monitor a patient's blood cells before they receive each dose of Halaven, and should monitor them more often if they develop lower white blood cells. If a patient develops severe neutropenia lasting longer than 7 days or neutropenia with a fever, their next dose of Halaven should be delayed and reduced. Severe neutropenia occurred in 57% (287/503) of patients who received Halaven and lasted more than 1 week in 12% (62/503) of patients. Neutropenia with a fever occurred in 5% (23/503) 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. Patients should call their healthcare provider immediately if they have any of the following symptoms: fever (temperature above 100.5 degrees F), chills, coughing, burning or pain when they urinate.
Nerve Disorders (Peripheral Neuropathy)
Halaven can cause numbness, tingling, or burning in a patient's hands and feet (peripheral neuropathy). A patient should be monitored closely for signs of neuropathy. If a patient develops 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% (42/503) of patients who received Halaven. Neuropathy lasting more than one year occurred in 5% of patients. Twenty-two percent (109/503) 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 receiving Halaven.
Pregnancy and Nursing
Halaven may harm a patient's unborn baby. A patient should avoid becoming pregnant while they are receiving Halaven. A patient should tell their healthcare provider right away if they become pregnant or think they are pregnant while they are receiving Halaven. The patient and their healthcare provider should decide if they will receive Halaven or breastfeed. A patient should not do both.
Halaven can cause changes in a patient's heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death. A patient's healthcare provider will decide if they need heart monitoring (electrocardiogram or ECG), or blood tests during their treatment with Halaven to watch for this problem.
Liver and Kidney Problems
In patients with mild or moderate liver problems, and/or moderate kidney problems, a lower starting dose of Halaven is recommended.
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 (82%), low red blood cells (58%), weakness/tiredness (54%), hair loss (45%), numbness, tingling or burning in the hands and feet (35%), nausea (35%), and constipation (25%). The most common serious side effects reported in patients receiving Halaven were neutropenia with or without a fever (4% and 2%, respectively).
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 can help 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 is to help address unmet medical needs and to increase the benefits health care provides to patients and their families. 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, biologic and supportive care agents for cancer across multiple indications.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.
Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit 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 throughout the world. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system.
|SOURCE Eisai Inc.|
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