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Chugai Files NDA for an Anti-Tumor Agent, Erlotinib (Epidermal Growth Factor Receptor (EGFR/HER1) Tyrosine Kinase Inhibitor).

Tokyo, Japan, Apr 17, 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.

Source: Chugai Pharmaceutical Co., Ltd.

Mamoru Togashi
General Manager,
Corporate Communications Dept.

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Publication:JCN Newswires
Geographic Code:9JAPA
Date:Apr 18, 2006
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