Roche Requests Re-Examination of CHMP Opinion on Tarceva in Pancreatic Cancer at the European Medicines Agency

Roche Requests Re-Examination of CHMP Opinion on Tarceva in Pancreatic Cancer at the European Medicines Agency

September 05, 2006

-- First Treatment for Years to Have Shown a Significant Survival Benefit for Patients

    BASEL, Switzerland, Sept. 5 /Xinhua-PRNewswire/ --
Roche announced today that it has requested a
re-examination of the data supporting the filing of their
breakthrough cancer medicine, Tarceva, for the treatment of
pancreatic cancer following the recent negative opinion from
the European Committee for Medicinal Products for Human Use
(CHMP).

    The filing was specifically for the use of Tarceva
(erlotinib) in combination with gemcitabine chemotherapy
for the first line treatment of advanced pancreatic cancer.
Pancreatic cancer is one of the most aggressive forms of
cancer killing more people within the first year of
diagnosis than any other cancer.(1) People with pancreatic
cancer have limited treatment options and Tarceva is the
first treatment for many years to have shown a significant
survival benefit in patients with pancreatic cancer.

    "People with pancreatic cancer need new treatment
options like Tarceva which has been proven in clinical
trials to significantly increase survival and has already
been approved for this indication in the US," said
Eduard Holdener, Head of Global Drug Development. "In
light of this, we are asking the CHMP to re-consider its
opinion."

    Tarceva was granted a licence by the American FDA (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 license applications
are based on data from the Phase III study (PA3)(2) which
showed that treatment with Tarceva plus gemcitabine results
in significantly longer survival (22%) compared to
gemcitabine alone. 24% of patients receiving Tarceva plus
gemcitabine were alive after one year, compared to 19% on
gemcitabine alone.

    Roche and its partners are committed to realising the
potential of Tarceva in treating pancreatic cancer through
its extensive clinical trial programme, including a
Roche-sponsored randomised, 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 randomised 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 PA3(2) 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;
expected rash and diarrhoea were the principal
Tarceva-related side effects seen in the study and were
generally characterised 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 tumour 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 a small molecule that targets
the human epidermal growth factor receptor (HER1) pathway.
HER1, also known as EGFR, is a key component of this
signalling pathway, which plays a role in the formation and
growth of numerous cancers. Tarceva blocks tumour cell
growth by inhibiting the tyrosine kinase activity of the
HER1 signalling 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
tumour 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 the first-line 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, focussing 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 tumours,
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 totalled 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

    For more information, please contact:

    Roche Group Media Office

     Baschi Durr, Alexander Klauser or Martina Rupp, or
     Daniel Piller, Head of Roche Group Media Office, or
     Katja Prowald, Head of R&D Communications
     Tel:   [phone]
     Email: [e-mail] 

SOURCE  Roche