Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereafter, Chugai)] announced today that bevacizumab (genetical recombination), a humanized anti-VEGF (Vascular Endothelial Growth Factor) monoclonal antibody (brand name: Avastin(R) for intravenous infusion 100mg/4mL or 400mg/16mL) obtained approval today from the Japanese Ministry of Health, Labour and Welfare for the treatment of advanced or refractory colorectal cancer who is not the candidate for the curative operation.
TOKYO, Japan | Apr 18, 2007 | Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereafter, Chugai)] announced today that bevacizumab (genetical recombination), a humanized anti-VEGF (Vascular Endothelial Growth Factor) monoclonal antibody (brand name: Avastin(R) for intravenous infusion 100mg/4mL or 400mg/16mL) obtained approval today from the Japanese Ministry of Health, Labour and Welfare for the treatment of advanced or refractory colorectal cancer who is not the candidate for the curative operation.
A new drug application for Avastin(R) was filed in April 21, 2006 based on Japanese Phase I study data, along with supporting overseas Phase II and III data, following the recommendation made by the fifth Investigational Committee for Usage of Unapproved Drugs in July 2005.
In Japan, a phase I clinical trial of Avastin(R) combined with 5-FU/l-LV and a Safety Confirmation Study of Avastin(R) combined with FOLFOX4 therapy are conducted, and the pharmacokinetics and tolerability has been confirmed. The approval was granted based on the data of these two domestic studies, as well as overseas studies.
Avastin(R) is a drug with the new mode of action of inhibiting angiogenesis. The conditions for approval were given as: "Because of a very limited number of the subjects treated in the domestic clinical trials, a post-marketing surveillance of all patients who received Avastin(R) after the launch of it should be conducted until the data of a certain number of patients are accumulated in order to identify the background of the patients and collect the safety and efficacy data of them early, and take necessary measures for proper use of Avastin(R)."
Putting the top priority to ensuring the safety of the patients and the implementation of the proper use of Avastin(R), for a certain time period after launch, the use of Avastin(R) should be limited to the medical institutions which have the sufficient experience in cancer chemotherapy and the ability to provide the effective emergency treatment to the adverse reactions such as gastrointestinal perforations and hemorrhage, and which are willing to cooperate in the post-marketing surveillance involving the registry of every single patient.
Colorectal cancer is one of the most common cancers in Japan, with an estimated 115,000 new patients in 2005*. The approval of Avastin(R) in Japan provides a new option in the treatment of colorectal cancer and will contribute to the patients and healthcare professionals via the treatment of the disease. Making the safety of the patients a top priority, Chugai will make every effort to collect and provide information on the proper use of Avastin(R).
*A. Oshima, T. Kuroishi, K. Tajima, "Cancer White Paper -Incidence/Death/Prognosis – 2004"
[References]
Brand name: Avastin(R) for intravenous infusion 100mg/4mL
Avastin(R) for intravenous infusion 400mg/16mL
Generic name: Bevacizumab (genetical recombination)
Indication: Advanced or refractory colorectal cancer who is not the candidate for the curative operation.
Dosage and administration:
The usual adult dosage of AVASTIN is 5 mg/kg (body weight) or 10 mg/kg (body weight) per intravenous infusion in combination with other anti-cancer chemotherapy. The administration interval of Avastin should be 2 weeks or longer.
About the post marketing surveillance of Avastin(R)
The post marketing surveillance covering all patients who received Avastin(R) is planned to collect the data of 2,500 cases to complete within 18 months, and to be continued until the safety of the product in Japanese population is confirmed. After collecting the data of 2,500 cases, Chugai will review them and make a decision carefully if the surveillance should be terminated considering the necessity of the continuation or change of the methodology and/or contents of the survey.
Results of this surveillance shall be reported to the public in future scientific meetings, as well as to the regulatory authorities.
About Avastin(R)
Avastin(R) 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). Avastin(R) is approved in 88 countries including US and Europe as of July, 2006.
SOURCE: Chugai Pharmaceutical Co., Ltd.
