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TARCEVA IN PANCREATIC CANCER
De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
Assunto: In the Interests of Patients, Roche
Will Consider All Options Following CHMP Opinion
on Tarceva in Pancreatic Cancer
28 de julho de 2006 13:39 HORALOCAL
In the Interests of Patients, Roche Will
Consider All Options
Following CHMP Opinion on Tarceva in Pancreatic
Cancer
BASEL, Switzerland, July 28 /PRNewswire/ --
Roche announced today
that its cancer medicine Tarceva (erlotinib) has
received a negative
opinion from the European Committee for
Medicinal Products for Human
Use (CHMP) for use in combination with
gemcitabine chemotherapy for
the first line treatment of advanced pancreatic
cancer, a cancer with
an extremely high fatality rate(1). Roche is
confident in the trial
data, which has shown that the Tarceva
combination treatment
significantly increases patient survival. In the
interest of the
patients, Roche will now consider all options
following this
decision, including requesting a re-examination
of this decision.
Tarceva has already been approved by the
American Food and Drug
Administration in November 2005 for the
first-line treatment of
patients with locally advanced, unresectable or
metastatic pancreatic
cancer in combination with gemcitabine
chemotherapy. Both the US and
the EU application are based on data from the
Phase III study
(PA3)(2) which showed that treatment with
Tarceva plus gemcitabine
results in significantly longer survival
compared to gemcitabine
alone (22%). In addition, 24% of patients
receiving Tarceva plus
gemcitabine were alive after one year, compared
to 19% on gemcitabine
alone.
"Pancreatic cancer is one of the most aggressive
forms of cancer and
it kills more people within the first year of
diagnosis than any
other cancer," said Eduard Holdener, Head of
Global Drug Development.
"Given such a poor outlook, even modest
improvements in survival are
valuable to advanced stage patients."
Despite significant advances in the treatment of
many other tumors,
the five year survival rate for men and women
diagnosed with
pancreatic cancer has not changed in decades(1).
Treatment options
for patients are extremely limited and Tarceva
is the first treatment
for many years to have shown a significant
survival benefit in
patients with pancreatic cancer.
Roche and its partners are committed to
realizing the potential of
Tarceva in treating pancreatic cancer through
its extensive clinical
trial programme, including a Roche-sponsored
randomized, double
blind, placebo controlled study of gemcitabine
and Tarceva+/- Avastin
in patients with metastatic pancreatic cancer (AVITA
or BO17706).
Tarceva is approved and marketed in the US and
across the European
Union for patients with locally advanced or
metastatic non-small cell
lung cancer (NSCLC) after failure of at least
one prior chemotherapy
regimen.
A variation application was submitted to the
European Health
Authorities in October 2005 for Tarceva plus
gemcitabine chemotherapy
for the first-line treatment of patients with
advanced pancreatic
cancer. In April 2006, Chugai Pharmaceutical Co.,
Ltd. filed a New
Drug Application (NDA) with the Japanese
Ministry of Health, Labour
and Welfare (MHLW) for Tarceva in patients with
advanced or recurrent
NSCLC.
About the PA3 study(2)
The pivotal Phase III randomized study (PA3)(2)
of 569 patients was
conducted by the National Cancer Institute of
Canada Clinical Trials
Group based at Queen's University. The double
blind study evaluated
Tarceva's efficacy in patients with locally
advanced or metastatic
pancreatic cancer.
The results of PA32 demonstrated the following:
-- Treatment with Tarceva plus gemcitabine in
patients with advanced
pancreatic cancer resulted in significantly
longer survival compared
to gemcitabine alone (22%)
-- 24% of patients receiving Tarceva plus
gemcitabine were alive
after one year, compared to 19% on gemcitabine
alone
-- Patients receiving Tarceva plus gemcitabine
experienced
significantly longer progression-free survival
of 30%
-- Tarceva plus gemcitabine was well tolerated
by patients with no
increase in haematological toxicity; as expected
rash and diarrhoea
were the principal Tarceva-related side effects
seen in the study and
were generally characterized as mild-to-moderate
-- Tarceva plus gemcitabine reported a safety
profile generally
consistent with that seen in other studies both
monotherapy and
combination settings
About pancreatic cancer
Pancreatic cancer is the tenth most frequently
occurring cancer in
Europe(3) The main risk factors for pancreatic
cancer include
advanced age, cigarette smoking, a high-fat diet,
diabetes mellitus,
chronic inflammation of the pancreas (pancreatitis),
especially
hereditary pancreatitis, and a family history of
pancreatic
cancer(4). The symptoms vary depending upon
where the tumor is in the
pancreas. The major symptoms are weight loss,
abdominal pain and
jaundice(1). The disease is rapidly fatal and
attempts to improve
survival over the past 10 years have been
unsuccessful.
About Tarceva
Tarceva (erlotinib) is an investigational small
molecule that targets
the human epidermal growth factor receptor
(HER1) pathway. HER1, also
known as EGFR, is a key component of this
signaling pathway, which
plays a role in the formation and growth of
numerous cancers. Tarceva
blocks tumor cell growth by inhibiting the
tyrosine kinase activity
of the HER1 signaling pathway inside the cell.
Taken as an oral, once-daily therapy, Tarceva is
the only
EGFR-inhibitor to have demonstrated a survival
benefit in lung cancer
-- a striking 42.5%. Currently most lung cancer
patients are treated
with chemotherapy, which can be very
debilitating due to its toxic
nature. Tarceva works differently to
chemotherapy by specifically
targeting tumor cells, and avoids the typical
side-effects of
chemotherapy.
Tarceva is approved in the US and across the EU
for patients with
locally advanced or metastatic non-small cell
lung cancer (NSCLC)
after failure of at least one prior chemotherapy
regimen.
Tarceva has been approved by the FDA since
November 2, 2005 for
treatment of locally advanced, unresectable or
metastatic pancreatic
cancer in combination with gemcitabine
chemotherapy.
Tarceva is currently being evaluated in an
extensive clinical
development programme by a global alliance among
OSI Pharmaceuticals,
Genentech, and Roche, focusing on earlier stages
of NSCLC.
Additionally, Tarceva is being studied in
combination with Avastin in
NSCLC. Trials are also being conducted with
Tarceva in other solid
tumors, such as ovarian, bronchioloalveolar (BAC),
colorectal,
pancreatic, head and neck and glioma (brain).
About Roche
Headquartered in Basel, Switzerland, Roche is
one of the world's
leading research-focused healthcare groups in
the fields of
pharmaceuticals and diagnostics. As a supplier
of innovative products
and services for the early detection, prevention,
diagnosis and
treatment of disease, the Group contributes on a
broad range of
fronts to improving people's health and quality
of life. Roche is a
world leader in diagnostics, the leading
supplier of medicines for
cancer and transplantation and a market leader
in virology. In 2005
sales by the Pharmaceuticals Division totaled
27.3 billion Swiss
francs, and the Diagnostics Division posted
sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000
people in 150 countries and
has R&D agreements and strategic alliances with
numerous partners,
including majority ownership interests in
Genentech and Chugai.
Additional information about the Roche Group is
available on the
Internet (http://www.roche.com).
All trademarks used or mentioned in this release
are protected by
law.
For further information about:
- Cancer: http://www.health-kiosk.ch
- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
- Genentech: http://www.gene.com
- OSI Pharmaceuticals: http://www.osip.com
References:
1. Steward, B W and Kleihues, P. 2003. World
Cancer Report. World
Health Organisation and the International Agency
for Research on
Cancer, IARC Press/Lyon, p248
2. Moore MJ, Goldstein D, Hamm J, et al.
Erlotinib plus gemcitabine
compared to gemcitabine alone in patients with
advanced pancreatic
cancer. A Phase III trial of the National Cancer
Institute of Canada
Clinical Trials Group (NCIC-CTG). (Abstract #1,
ASCO 2005)
3. De Braud F, Cascinu S, Gatta G. 2004, May.
Cancer of Pancreas.
Critical reviews in oncology/hematology,
50(2):147-55
4. Truninger K (ed). 2002, Aug. Risk groups for
pancreatic and bile
duct carcinomas. Schweizerische Rundschau fur
Medizin Praxis, 17;89
(33):1299-304
SOURCE Roche
07/28/2006
CONTACT: Roche Group Media Office:
+41-61-688-8888,
basel.mediaoffice@roche.com - Baschi Durr -
Alexander Klauser -
Daniel Piller - Head of Roche Group Media Office
- Katja Prowald -
Head of R&D Communications - Martina Rupp
BNED: NG
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
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BRASIL-NÉLIA GARCIA
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PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: INDÚSTRIA
FARMACÊUTICA
PALAVRA-CHAVE/EMPRESA: ROCHE
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