Chugai Files NDA For An Anti-Tumor Agent, Bevacizumab For Advanced Or Recurrent Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: GastroIntestinal / Gastroenterology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 23 Apr 2006 - 0:00 PDT

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Chugai Pharmaceutical Co., Ltd. announced today that Chugai has filed a new drug application (NDA) for bevacizumab for advanced or recurrent colorectal cancer with the Japanese Ministry of Health, Labour and Welfare (MHLW).

This filing is based on a Japanese Phase I study, along with supporting US and/or European Phase II and III data, following the recommendation made by the fifth Investigational Committee for Usage of Unapproved Drugs as of July 2005. Bevacizumab is the first medicine to be filed without Japanese Phase II study for a major indication such as colorectal cancer since the establishment of this committee. As a result, the filing schedule was shortened by almost 18 months, compared to Chugai's original plan. In 2005, colorectal cancer was one of the most commonly reported cancers, with an estimated incidence of 115,000 people in Japan*.

The Japanese Phase I study was conducted in 18 patients with metastatic carcinoma of the colon or rectum in combination with 5-fluorouracil/folinic acid. The results confirmed bevacizumab's pharmacokinetics and safety in Japanese patients.

Requested by MHLW, we are currently carrying out the Safety Confirmation Study, which was recommended to be conducted by the investigational committee.

*A.Oshima, T.Kuroishi, K.Tajima, "Cancer White Paper - Incidence/Death/Prognosis - 2004"

About bevacizumab

Bevacizumab is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. It 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). Currently, bevacizumab is marketed in the US and Europe, under the product name of Avastin®.

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.

About Safety Confirmation Study

Safety Confirmation Study is a study implemented for enhancing proper drug usage at the time of approval, assuming post-approval drug utilization by understanding clinical results. In cases for which post-marketing trials were required in the past, Safety Confirmation Study requires the post-marketing trials to be conducted ahead of the approval. Similar trials are being required as Phase IIIb outside Japan and it is becoming a necessity from the perspective of international harmonization.
(Quoted from the third Investigational Committee for Usage of Unapproved Drugs)

http://www.chugai-pharm.co.jp

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