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Basel, 21 April 2006
Chugai files innovative
cancer medicine Avastin for fast approval in Japan
Faster approval process aims
to make Avastin available to patients as soon as possible
Roche today
announced that Chugai has submitted a New Drug Application (NDA) with the Japanese Ministry of Health,
Labour and Welfare (MHLW) for the use of Avastin (bevacizumab) in patients with advanced or recurrent
colorectal cancer.
Avastin has been filed under a new ‘fast regulatory’
scheme that has been established by the Investigational Committee for Usage of Unapproved Drugs (a body
established by the MHLW). The system has been set up to enable faster regulatory approval of certain
medicines with proven efficacy which are approved in the US and/or Europe but that are not yet available
in Japan. Avastin is the first medicine to be filed under this scheme for an indication as significant
as colorectal cancer.
“Today’s submission comes just after Tarceva’s
initial filing in advanced or recurrent non-small cell lung cancer and represents a further significant
milestone for oncologists and patients in Japan. The Japanese authorities have recognized that Avastin
is a breakthrough drug which addresses an unmet medical need for patients suffering with advanced colorectal
cancer” said Ed Holdener, Head of Roche’s Global Pharma Development. “We will continue to work closely
with the Investigational Committee to ensure that this groundbreaking treatment becomes available to
colorectal cancer patients as quickly as possible.”
The Avastin filing
is based on local Phase I data, along with supporting US and European Phase II and pivotal Phase III
data1,2,3. At the same time, Chugai is conducting a Safety Confirmation Study
in order to provide data on Japanese patients during the review procedure.
In
Japan, the incidence of colorectal cancer has increased significantly in the last 50 years and research
interest in this cancer has grown rapidly among Japanese clinicians and pathologists4.
In 2005, colorectal cancer was one of the most commonly reported cancer with an estimated incidence
of 115,000 people in Japan5.
Avastin is the
first and only anti-angiogenic agent to have demonstrated improved overall and/or progression-free survival
in the three major types of cancer leading to death: colorectal cancer, non-small cell lung cancer and
breast cancer. In Europe, Avastin was approved early 2005 for first-line treatment of patients with
metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous
5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received
approval by the US Food and Drug Administration (FDA) in February 2004. In addition, filing occurred
in the US on April 10, 2006, for use of Avastin in previously untreated advanced non-squamous, non-small
cell lung cancer.
Data used for filing
The
local Phase I study was conducted in 18 patients with metastatic carcinoma of the colon or rectum to
investigate the pharmacokinetics and safety of Avastin in Japanese patients when used in combination
with 5-fluorouracil/folinic acid.
A Phase II study (AVF2192) demonstrated
that Avastin, when added to a combination of 5-fluorouracil/folinic acid, prolonged the time until disease
progression or death by an extra four months compared to chemotherapy alone (a 67% increase in progression-free
survival).
In the Phase III pivotal trial (AVF2107), patients with previously
untreated metastatic carcinoma of the colon or rectum (mCRC) who received Avastin in combination with
intravenous 5-fluorouracil/folinic acid/irinotecan lived significantly longer than patients receiving
the same chemotherapy without Avastin- on average by nearly five months (20.3 months versus 15.6 months).
Also, the addition of Avastin increased the amount of time that patients were without disease progression,
on average four months, compared to patients receiving chemotherapy alone (10.6 months versus 6.2 months).
In
a second Phase III study (E3200), conducted by the Eastern Cooperative Oncology Group (ECOG), Avastin
was also shown to significantly improve survival when added to another widely prescribed chemotherapy
regimen (oxaliplatin/5-fluorouracil/leucovorin). With Avastin, patients who had failed previous irinotecan
or 5-FU containing chemotherapy for their disease, lived nearly two months longer, on average, compared
to those who received chemotherapy alone (12.9 months vs. 10.8 months).
About
Avastin
Avastin is the first treatment that inhibits angiogenesis, which is defined
as the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin
targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator
of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and
its spread throughout the body (metastasis). Roche and Genentech are pursuing a comprehensive clinical
programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung,
pancreatic, ovarian cancer, renal cell carcinoma and others) and different settings (advanced, adjuvant
and neoadjuvant) The total development program is expected to include over 25,000 patients worldwide.
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 (www.roche.com).
All
trademarks used or mentioned in this release are legally protected.
Further
information
- Chugai Pharmaceutical Co.
- Roche
in oncology
- Cancer
References
1.
Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin
for Metastatic Colorectal Cancer. New England Journal of Medicine 2004; 350(23): 2335–2342
2.
Kabbinavar FF, Joseph Schulz J, McCleod M, et al. Addition of Bevacizumab to Bolus 5-FU/Leucovorin in
First-Line Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial.) J Clin Oncol 23:10.1200/JCO.2005.05.112,
2005
3. Mitchell EP, Alberts SR, Schwartz BJ, et al. High-dose bevacizumab in combination
with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results
from the Eastern Cooperative Oncology Group (ECOG) study E3200. ASCO Gastrointestinal 2005 Cancer Symposium,
January 2005 (abstract 169a)
4. Koyame Y, Kotake K. Overview of colorectal cancer in
Japan: report from the Registry of the Japanese Society for Cancer of the Colon and Rectum.; Dis Colon
Rectum 1997, Oct, 40 (10 Suppl): S2-9.
5. A.Oshima, T.Kuroishi, K.Tajima, Cancer White
Paper -Incidence/Death/Progonosis - 2004
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Avastin: delivers patient survival benefits in different cancer types
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