WOODCLIFF LAKE, N.J., Oct. 26, 2015 /PRNewswire/ -- Eisai Inc. announced today that Halaven® (eribulin mesylate) Injection has been nominated by the Galien Foundation within the category, "Best Pharmaceutical Agent of the Year" at the ninth annual Prix Galien USA Awards.
The Prix Galien, set up in France by pharmacist Roland Mehl and since expanded across Europe, Canada and the U.S., is designed to recognize the technical, scientific and clinical research skills necessary to develop innovative medicines and devices. Nominees include biomedical products across three categories, biotechnology, pharmaceutical, and technology products, that advance human health and which have been approved by the U.S. Food and Drug Administration during the past five years.
"We are honored that Halaven, which was discovered and developed at Eisai, has been nominated for this prestigious award," said Kenichi Nomoto, Ph.D., President, Oncology Product Creation Unit, Eisai Product Creation Systems. "Halaven plays an important role as a third-line treatment for patients with metastatic breast cancer, providing a much-needed additional treatment option for these patients."
The Prix Galien USA Committee is comprised of 10 renowned leaders from the biomedical industry and academia, including five Nobel Laureates, and is responsible for evaluating nominees. Winners will be honored at the Prix Galien USA Awards Ceremony on October 27, 2015 at 6:30 p.m., at the American Museum of Natural History in New York City.
For further information on The Galien Foundation Prix Galien Awards, please visit: http://www.prnewswire.com/news-releases/the-galien-foundation-announces-2015-prix-galien-usa-nominees-for-best-biotechnology-product-best-pharmaceutical-agent-and-best-medical-technology-300124894.html
About Halaven® (eribulin mesylate) Injection
Halaven, the first agent in the halichondrin class, is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic breast cancer. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. Halaven is a synthetic analog of halichondrin B, a natural product that was isolated from the marine sponge Halichondria okadai.
Important Safety Information
- Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days
- Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels
- Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received Halaven. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications
- Patients should be monitored closely for signs of peripheral motor and sensory neuropathy
- Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received Halaven. Delay administration of Halaven until resolution to Grade 2 or less
- 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 within a median follow-up duration of 269 days (range 25-662 days)
- Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation
Pregnancy Category D
- Halaven is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks
- In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of Halaven concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias; concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities
- Correct hypokalemia or hypomagnesemia prior to initiating Halaven® and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome
Hepatic and Renal Impairment
- For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate or severe (CrCl 15-49 mL/min) renal impairment, a reduction in starting dose is recommended
Most Common Adverse Reactions
- Most common adverse reactions (>25%) reported in patients receiving Halaven were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%)
- The most common serious adverse reactions reported in patients receiving Halaven were febrile neutropenia (4%) and neutropenia (2%)
For more information about Halaven, click here for the full Prescribing Information.
About 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., we have a passionate commitment to patient care that 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 and Pennsylvania, as well as a global demand chain organization that includes 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.
SOURCE Eisai Inc.
Type Press Release
Date Released October 26, 2015