Sponsored by
Most Common and Aggressive Form of Brain Cancer
KENILWORTH, N.J., June 10 /PRNewswire-FirstCall/ -- Schering-Plough
Corporation (NYSE: SGP) today announced that the European Commission has
granted approval of TEMODAL(R) (temozolomide) Capsules for first-line use for
the treatment of patients with newly diagnosed glioblastoma multiforme (GBM),
the most common and aggressive form of primary brain cancer. The approval
follows a positive opinion granted on April 21, 2005, by the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines Agency
(EMEA).
The approval of TEMODAL in combination with radiotherapy followed by up to
six cycles of TEMODAL monotherapy is valid in the current 25 EU Member States
as well as in Iceland and Norway. The approval is based largely on efficacy
and safety data from the landmark Phase III study conducted by the European
Organisation for Research and Treatment of Cancer (EORTC) and the National
Cancer Institute of Canada (NCIC) Clinical Trial Group.
These data were published in the March 10, 2005, edition of the New
England Journal of Medicine. In this multicenter trial of 573 patients with
newly diagnosed GBM, significant improvement in overall survival was observed
in patients who were treated with TEMODAL in combination with radiotherapy
compared with those treated with radiotherapy alone.
"Newly diagnosed GBM patients and their physicians now have an opportunity
to combat this most aggressive brain tumor in its early stages. As
demonstrated in our clinical trial, TEMODAL provides a significant improvement
in survival compared to standard therapy," said Roger Stupp, M.D., University
Hospital Multidisciplinary Oncology Centre in Lausanne, Switzerland and lead
investigator of the EORTC/NCIC trial.
"It is important for patients throughout the EU to have access to this
important treatment advance for this devastating disease," said Robert J.
Spiegel, M.D., chief medical officer and senior vice president of medical
affairs, Schering-Plough Research Institute.
The study results showed that 26 percent of the patients in the TEMODAL
group will survive two years or longer, as compared to 10 percent for those
who received radiotherapy alone, doubling the survival rate at two years.
Median survival in the TEMODAL group was also significantly better (14.6 vs.
12.1 months) compared to the radiotherapy only group. TEMODAL treatment was
generally well tolerated; the most commonly observed adverse events (greater
than 10%) in patients receiving TEMODAL in combination with radiotherapy
followed by TEMODAL monotherapy included decreased appetite, headache,
constipation, nausea, vomiting, hair loss, rash, convulsions, fatigue,
diarrhea, stomatitis and blurred vision. Low white blood cells and low
platelets, which are known dose-limiting toxicities for most cytotoxic agents,
including TEMODAL, were observed. When laboratory abnormalities and adverse
events were combined across concomitant and monotherapy treatment phases,
Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were
observed in 8 percent of the patients. Grade 3 or Grade 4 thrombocyte
abnormalities, including thrombocytopenic events were observed in 14 percent
of the patients who received TEMODAL.
About Gliomas
Glioblastoma multiforme (GBM) is a rapidly growing neuroglia cell tumor of
the central nervous system, most often located in the cerebrum. It is the
most common and deadliest type of primary brain tumor. GBM is more common
among males and occurs more frequently in Caucasians. The median age at which
people are diagnosed with GBM is 50 to 60 years. In Europe, an estimated
10,000 patients are diagnosed with glioblastoma multiforme each year in EU
member countries.
About Temozolomide
Temozolomide is an oral, cytotoxic alkylating agent. Cytotoxic agents are
designed to prevent the replication of cells that divide rapidly, including
those in tumors. The development of temozolomide for expanded indications is
consistent with Schering-Plough's strategy to broaden its oncology portfolio
and is in line with its plans to build strength in its global franchises
through both internal research and external collaborations and licensing
opportunities.
TEMODAL was first approved in the EU in 1999 for the treatment of patients
with glioblastoma multiforme, showing recurrence or progression after standard
therapy. TEMODAL was subsequently approved for the treatment of patients with
malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma,
showing recurrence or progression after standard therapy. Schering-Plough
received full approval of temozolomide (TEMODAR(R)) from the U.S. Food and
Drug Administration (FDA) in March 2005 for the treatment of adult patients
with newly diagnosed GBM when administered in combination with radiotherapy
and then as maintenance therapy.
Important Information Regarding U.S. Labeling for TEMODAR with Newly
Diagnosed GBM
Patients treated with TEMODAR Capsules may experience myelosuppression.
Grade 3/4 neutropenia occurred in 8 percent and Grade 3/4 thrombocytopenia in
14 percent of patients treated with temozolomide. Geriatric patients and
women have been shown in clinical trials to have a higher risk of developing
myelosuppression. TEMODAR Capsules are contraindicated in patients who have a
history of hypersensitivity to any of its components, or to DTIC. Caution
should be exercised when administered to those with severe hepatic or renal
impairment. TEMODAR may cause fetal harm when administered to a pregnant
woman. Nursing should be discontinued in women receiving TEMODAR. The
effectiveness of TEMODAR in children has not been established. TEMODAR
Capsules should not be opened or chewed. If capsules are accidentally opened
or damaged, rigorous precautions should be taken with the capsule contents to
avoid inhalation or contact with the skin or mucous membranes. Prophylaxis
against Pneumocystis carinii pneumonia (PCP) is required in all patients
receiving TEMODAR in combination with radiotherapy for the 42-day regimen.
There may be a higher occurrence of PCP when temozolomide is administered
during a longer dosing regimen. All patients receiving TEMODAR, particularly
patients receiving steroids, should be observed closely for the development of
PCP regardless of the regimen. As noted in the U.S. package insert, during
the concomitant phase (TEMODAR plus radiotherapy), adverse events including
thrombocytopenia, nausea, vomiting, loss of appetite and constipation, were
more frequent in the TEMODAR plus radiotherapy arm versus the radiotherapy arm
alone. The incidence of other adverse events were comparable in the two arms.
The most common adverse events across the cumulative TEMODAR experience were
hair loss, nausea, vomiting, decrease in appetite, headache and constipation.
Schering-Plough Corporation is a global science-based health care company
with leading prescription, consumer and animal health products. Through
internal research and collaborations with partners, Schering-Plough discovers,
develops, manufactures and markets advanced drug therapies to meet important
medical needs. Schering-Plough's vision is to earn the trust of the
physicians, patients and customers served by its more than 30,000 people
around the world. The company's Web site is http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
includes certain "forward-looking statements" within the meaning of the
Securities Litigation Reform Act of 1995, including the market for drugs to
treat GBM and the company's strategy. Forward-looking statements relate to
expectations or forecasts of future events and use words such as "estimated"
and "plans." Actual results may vary materially from the forward-looking
statements, and there are no guarantees about the performance of
Schering-Plough stock or Schering-Plough's business. Schering-Plough does not
assume the obligation to update any forward-looking statement. Many factors
could cause actual results to differ from Schering-Plough's forward-looking
statements. These factors include uncertainties in the regulatory process,
market acceptance of TEMODAL, manufacturing issues, current and future branded
and generic competition, timing of trade buying, and difficulties in product
development. For further details about these and other factors that may
impact the forward-looking statements, see Schering-Plough's Securities and
Exchange Commission filings, including the company's first quarter 2005 10-Q.
NOTE TO EDITORS: Schering-Plough press releases are available on the
company's Web site at http://www.schering-plough.com
Schering-Plough press releases are also available on PRNewswire's Web site
at http://www.prnewswire.com/comp/777050.html
SOURCE Schering-Plough Corporation
Web Site: http://www.schering-plough.com
Company News On Call: Company News On-Call:
http://www.prnewswire.com/comp/777050.html