Gliadel® Wafer approved by Health Canada for patients with Glioblastoma
MISSISSAUGA, ON, Nov. 3, 2011 /CNW/ - Eisai Limited, a wholly-owned
Canadian subsidiary of Eisai Inc., announced today the Health Canada
approval and availability of Gliadel® Wafer (carmustine implant in polifeprosan 20) indicated in recurrent
Glioblastoma Multiforme (GBM) patients for whom surgical resection is
indicated as an adjunct to surgery.
There are more than 120 types of brain tumoursi, causing a diagnostic and treatment challenge for physicians. GBM is
one of the most progressive and fatal types. An estimated 55,000
Canadiansii are currently dealing with some form of brain tumour, highlighting a
need for new options to treat these aggressive cells.
"Eisai is pleased to continue our patient-focused corporate mission in
Canada with the approval of Gliadel®, a dime-sized wafer that delivers chemotherapy directly into the affected
area of the brain," says Takihiro Hirasawa, President, Eisai Limited.
"We are proud to offer an additional treatment option for patients who
suffer from brain tumours."
The approval of Gliadel® was based on a pivotal trial in patients with recurrent glioblastoma
multiforme treated with Gliadel® who experienced an increased six-month survival rate when compared to
treatment with placebo (56% with Gliadel® compared to 36% with placebo). Both Gliadel® and placebo were used as an adjunct to surgery.
Brain tumours are often classified by cell origin and how the cells
behave, from the least aggressive (non-malignant) to the most
aggressive (malignant) and assigned a grade, ranging from Grade I
(least malignant) to Grade IV (most malignant), which signifies the
rate of growth. The classification and grade of a tumour helps to
predict its likely behaviour.
"A brain tumour diagnosis can be utterly devastating for a patient and
it is important to reinforce that there are treatment options that can
help to stop or slow the growth of cells and prolong survival," says,
Dr. Warren Mason, Neurooncologist, Gerry and Nancy Pencer Brain Tumour
Centre, Princess Margaret Hospital. "The approval of Gliadel®, which improved six-month survival rates, is another option and the
only chemotherapeutic implant approved by Health Canada to treat
Gliadel® Wafer, a novel approach to the treatment of recurrent GBM, is a
biodegradable wafer, implanted at the time of surgery that delivers
chemotherapy directly to the tumour site, minimizing drug exposure to
other areas of the body. Gliadel® Wafer complements other standard therapies for brain cancer, such as
surgery, radiation and chemotherapy.
"Brain Tumour Foundation of Canada is committed to providing people with
support, education and information as they navigate their journey with
a brain tumour," said Susan Marshall, Executive Director, Brain Tumour
Foundation of Canada. "An additional part of our mandate is to support
research in Canada. Every bit of information helps give hope to
thousands of Canadian families. We encourage brain tumour patients and
families to discuss all treatment options with their health care
Gliadel® has been approved and implanted in more than 15 countries including the
United States, Spain, Greece, U.K., France, Germany, Italy, Australia
and South East Asia. Since 1997, over 20,000 procedures have been
performed with Gliadel®.
Gliadel® Wafer is a small, dime-sized wafer that is designed to deliver a type
of chemotherapy, carmustine, directly into the cavity created when a
brain tumour is removed during surgery. Up to eight wafers are
implanted along the walls and floor of the cavity where the tumour was
previously located. Gliadel® slowly dissolves and delivers carmustine.
Gliadel® Wafer is the only Health Canada approved chemotherapeutic implant for
use during surgical resection.
Gliadel® Important Safety Information
Gliadel® should not be given to individuals who have demonstrated a previous
hypersensitivity to carmustine or any of the components of Gliadel®.
Patients undergoing craniotomy for malignant glioma and implantation of
Gliadel® should be monitored closely for known complications of craniotomy,
including seizures, intracranial infections, abnormal wound healing and
About Eisai Inc.
Eisai Inc. was established in 1995 and is ranked among the top-20 U.S.
pharmaceutical companies (based on retail sales). The company began
marketing its first product in the United States in 1997 and has
rapidly grown to become a fully integrated pharmaceutical business.
Eisai's areas of commercial focus include neurology, gastrointestinal
disorders and oncology/critical care. The company serves as the U.S.
pharmaceutical operating company of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the
Eisai Inc. 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
Eisai established Eisai Limited Canada in 2010. As a wholly-owned
subsidiary of Eisai Inc., Eisai Limited is based in Mississauga,
Ontario, one of the largest biopharmaceutical clusters and medical
communities in North America.
SOURCE Eisai Limited
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