Media Release
Basel, 26 August 2004 1 2 3
New
hope in fight against advanced lung cancer
Roche files marketing application for
Tarceva with European health authorities
Roche today submitted a Marketing
Authorisation Application to the European health authorities for its new cancer drug Tarceva (erlotinib)
for the treatment of advanced non-small cell lung cancer (NSCLC). NSCLC is the most common form of lung
cancer, which in itself is the most frequent cancer world wide. The application is based on data from
a pivotal clinical trial involving more than 700 patients with advanced NSCLC who had failed first or
second-line chemotherapy. Patients with advanced NSCLC treated with Tarceva achieved a significant improvement
(42%) in survival compared to those on placebo, along with improved symptom benefit
“The
benefits of Tarceva in this patient group are very compelling. Tarceva represents the first significant
advance in survival, among targeted therapies, for lung cancer patients who have failed available chemotherapy.
In the study, one out of three patients on Tarceva was alive at one year as opposed to only one of
five in the placebo group. We will work closely with regulatory authorities to bring Tarceva to patients
as quickly as possible” said William M Burns, Head of Roche Pharmaceuticals Division.
Lung
cancer is the most common cancer worldwide, accounting for 1.2 million new cases annually
Tarceva
is the first and only EGFR-targeted anticancer treatment to have shown a significant survival prolongation
in lung cancer. An application for approval of Tarceva in advanced NSCLC was also filed with the US
FDA this month.
Study Details
The
EU filing is based on results of the pivotal Phase III randomised trial (BR21) involving 731 patients,
which compared the use of Tarceva versus placebo for the treatment of patients with advanced NSCLC,
following failure of first or second-line chemotherapy. Patients receiving Tarceva lived significantly
longer than those in the placebo arm (6.7 months vs 4.7 months), an improvement of 42%.1 The study also
met all of its secondary endpoints including improving time to symptomatic deterioration, progression-free
survival and response rate. In addition, there was a 45% improvement in survival at one year and further
analysis showed treatment benefit over a broad spectrum of patients.
About
Tarceva
Tarceva 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 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. Results
of a Phase III trial of Tarceva in pancreatic cancer are expected during the second half of 2004 and
Tarceva is currently being evaluated in an extensive clinical development program by a global alliance
among OSI Pharmaceuticals, Genentech, and Roche. Chugai is pursuing its development and regulatory approval
for the Japanese market.
Roche in Oncology
Within
the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has
become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics.
Its oncology business includes an unprecedented four marketed products with survival benefit in different
major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s
lymphoma, and Avastin in colorectal carcinoma. In the United States Herceptin, MabThera and Avastin
are marketed either by Genentech alone or together with Biogen Idec Inc. Outside of the United States,
Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.
The
Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention
of skeletal events in breast cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril
(chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid
leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration
of the commitment to anaemia management. The Roche Group’s cancer medicines generated sales of more
than 3.3 billion Swiss francs in the first half of 2004.
Roche is developing
new tests, which will have a significant impact on disease management for cancer patients in the future.
With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach,
pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the
leaders in providing cancer focused treatments and diagnostics.
Roche
Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development
sites (two in the US, UK and Switzerland).
About Roche
Headquartered
in Basel, Switzerland, Roche is one of the world’s leading research-intensive healthcare groups. Its
core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services
for the 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 number one in the global diagnostics market,
the leading supplier of medicines for cancer and transplantation and a market leader in virology. In
2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while
the Diagnostics Division posted sales of 7.4 billion Swiss francs. Roche employs roughly 65,000 people
in 150 countries and has R&D agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai.
All
trademarks used or mentioned in this release are legally protected.
Reference:
1.
Shepherd, F.; A randomized placebo-controlled trial of erlotinib in patients with advanced non-small
cell lung cancer (NSCLC) following failure of 1st line or or 2nd line chemotherapy. A National Cancer
Institute of Canada Clinical Trials Group (NCIC). (Abstract #7022), ASCO 2004.
2. World
Health Organisation, World Cancer Report, 2003.
3. www.lungcancercoalition.org/cancer_facts.html.
Further information:
- Genentech: www.gene.com
- OSI Pharmaceuticals: www.osip.com
- Cancer: www.health-kiosk.ch