Tokyo, Japan, April, 2006 - (JCN Newswire) - Chugai Pharmaceutical Co.,
Ltd. (TSE: 4519) announced that the company filed a new drug application
(NDA) for erlotinib for advanced or recurrent non-small cell lung cancer
(NSCLC) with the Japanese Ministry of Health, Labour and Welfare (MHLW) as
of April 14, 2006.
Erlotinib is the only compound as an EGFR tyrosine kinase inhibitor for
which the survival benefit was proven with NSCLC. This was demonstrated in
a global double-blind phase III trial (BR.21) conducted by the National
Cancer Institute of Canada Clinical Trials Group/OSI/Genentech/ Roche , in
which patients with locally advanced or metastatic NSCLC after failure of
prior chemotherapy regimen were examined.
Lung cancer is one of the cancer types with poor prognosis. In Japan,
85,000 incidences were estimated in 2005*. After the US's approval for
erlotinib in November 2004, erlotinib was evaluated and recommended
continuing the phase II study running at that time by the Investigational
Committee for Usage of Unapproved Drugs in July 2005.
Recently, the phase II study conducted to evaluate erlotinib's efficacy
and safety in Japanese patients has been completed. The results confirmed
erlotinib's anti-tumor effect and tolerability in patients after failure
of prior chemotherapy regimen including platinum treatment.
About erlotinib
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 signalling pathway, which plays a role in the
formation and growth of numerous cancers. Erlotinib blocks tumour cell
growth by inhibiting the tyrosine kinase activity of the HER1 signalling
pathway inside the cell. Currently, erlotinib is marketed in more than 50
countries including the US and Europe, under the product name of
Tarceva(R).
About BR.21
BR.21 involved 731 patients with advanced NSCLC whose cancers had
progressed after first- or second-line chemotherapy. The study compared
patients receiving erlotinib monotherapy with placebo. Treatment with
erlotinib in patients with advanced NSCLC resulted in significantly longer
survival compared to placebo, a 42.5% improvement (6.7 months vs. 4.7
months).
About the Investigational Committee for Usage of Unapproved Drugs
In December 2004, the MHLW announced the establishment of a system
enabling the implementation of clinical trials, and streamlined systematic
usage, of certain medicines with proven efficacy which are approved in the
US and/or Europe but not yet available in Japan, in combination with
National Health Insurance-covered treatments. To drive the plan forward
the MHLW has formed the "Investigational Committee for Usage of Unapproved
Drugs" which consists of experts that are performing regular reviews and
scientific evaluations of drug usage requests from academic societies
and/or patients.
* A.Oshima, T.Kuroishi, K.Tajima, "Cancer White Paper - Incidence/Death/Prognosis - 2004"
About Chugai Pharmaceutical Co., Ltd.
Chugai Pharmaceutical Co., Ltd. is one of Japan's leading research-based
pharmaceutical companies with strengths in biotechnology products and in
the therapeutic fields of oncology, renal diseases, cardiovascular
diseases, bone/joint diseases and transplantation/infection/immunity. As a
most important member of the Roche group, we aim to become a top Japanese
pharmaceutical company by providing a continuous flow of innovative new
medicines domestically and internationally.
From the Japan Corporate News Network
Chugai Pharmaceutical Co., Ltd. - Company Profile
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