WOODCLIFF LAKE, N.J., Dec. 4, 2013 /PRNewswire/ -- Eisai Inc. announced today that five abstracts highlighting new study results will be presented during the 2013 San Antonio Breast Cancer Symposium. The meeting will be held December 10-14, 2013 at the Henry B. Gonzalez Convention Center in San Antonio, TX.
The studies highlight Eisai's current and ongoing clinical research efforts with eribulin mesylate, and reinforce the Company's commitment to metastatic breast cancer. Further, Eisai and its partner, Helsinn Group, will be presenting additional results of the pivotal Phase III study of the investigational oral compound, netupitant 300 mg + palonosetron 0.50 mg (NEPA), being studied for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) following both highly and moderately emetogenic chemotherapy.
"As part of Eisai's human health care mission, Eisai gives first thought to patients and their families by developing drugs for diseases with unmet medical need," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit at Eisai. "Nowhere is this more compelling than in oncology, one of Eisai's long-standing therapeutic areas of focus."
The following Eisai abstracts are accepted for presentation at this year's San Antonio Breast Cancer Symposium:
Eribulin mesylate as first-line therapy for locally recurrent or metastatic HER2-negative breast cancer: Results of a Phase II, multicenter, single-arm study
McIntyre et al.
Phase II, multicenter, single-arm study of eribulin mesylate + trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer
Wilks et al.
A Phase III, open-label, randomized study of eribulin versus capecitabine in patients (pts) with metastatic breast cancer (MBC): Effect of post-progression anti-cancer treatments (PPT) and metastatic progression events on overall survival
Awada et al.
Effect of age on tolerability and efficacy of eribulin and capecitabine in patients with metastatic breast cancer treated in study 301
Kaufman et al.
NEPA, a fixed-dose combination of netupitant and palonosetron, prevents chemotherapy-induced nausea and vomiting (CINV) more effectively and reduces the impact on daily living for breast cancer patients compared with palonosetron
Rugo et al.
The information discussed in this release is about investigational products or investigational uses for an FDA-approved product. It is not intended to convey conclusions of efficacy and safety.
Eribulin mesylate injection (known as Halaven®) is a non-taxane, microtubule dynamics inhibitor that is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai. Halaven is indicated for patients with breast cancer who have received at least two other types of anticancer medicines for their breast cancer once it has spread. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.
The FDA approval of Halaven in November 2010 was supported by results from EMBRACE, a phase III, randomized (2:1), open-label, multicenter, multinational trial in patients with metastatic breast cancer.
EMBRACE demonstrated a statistically significant OS benefit for patients treated with Halaven compared with a single-agent Treatment of Physician's Choice.
Important Safety Information
- Decreased White Blood Cells (Neutropenia)
- Doctors should do blood tests to monitor patients' blood cells before they receive each dose of HALAVEN, and should monitor them more often if they develop lower white blood cells.
- If patients develop 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% 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. Patients should call their healthcare providers 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). Patients should be monitored closely for signs of neuropathy. If they 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 one year occurred in 5% of patients. 22% 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. Patients must avoid becoming pregnant while they are receiving HALAVEN. They should tell their healthcare providers right away if they become pregnant or think they are pregnant while they are receiving HALAVEN.
- Patients and their healthcare providers should decide if they will receive HALAVEN or breastfeed. They should not do both.
- Heartbeat Changes
- HALAVEN can cause changes in a patient's heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death.
- Healthcare providers will decide if patients 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 >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 your 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).
Please see the HALAVEN full prescribing information.
About Netupitant 300 mg + Palonosetron 0.50 mg (NEPA)
NEPA is an investigational single-day, fixed-dose combination of a selective NK1 receptor antagonist, netupitant, and a 5-HT3 receptor antagonist, palonosetron, believed to target two critical pathways associated with chemotherapy induced nausea and vomiting (CINV). The Phase III investigational program for NEPA recently concluded.
About Helsinn and Eisai
Helsinn signed a licensing agreement with Eisai Inc. granting Eisai commercial rights for NEPA in the United States (if approved). Under the terms of the agreement, Helsinn is responsible for conducting all development activities (Chemistry and Manufacturing Controls [CMC], preclinical and clinical), obtaining regulatory approvals and holding the New Drug Application (NDA). If approved by the FDA, NEPA will be co-promoted in the United States by Eisai Inc. and Helsinn Therapeutics U.S. Inc., the U.S. company of the Swiss group.
About the Helsinn Group
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland, the United States and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in therapeutic niche areas. Helsinn is an important player in cancer supportive care. Helsinn Group in-licenses early-to-late stage new chemical entities, completes their development through the performance of pre-clinical/clinical studies and Chemistry, Manufacturing, and Control (CMC) development, and files and attains their market approvals worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how whom Helsinn assists and supports by providing a full range of product and scientific management services, including commercial, regulatory, financial, legal, and medical marketing advice. The active pharmaceutical ingredients and the finished products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland and supplied worldwide to its customers.
Further information on Helsinn Group is available at www.helsinn.com.
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 Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.
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