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On the Launch and Measures for Proper Use of the Anti-Cancer Agent Avastin

TOKYO, June 8, 2007 - Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; President Osamu Nagayama (hereafter, Chugai)] announced that bevacizumab (genetical recombination), a humanized anti-VEGF (Vascular Endothelial Growth Factor) monoclonal antibody (brand name: Avastin® for intravenous infusion 100mg/4mL or 400mg/16mL) which obtained approval on April 18 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, has been listed on National Health Insurance (NHI) drug reimbursement price list and will be launched on June 11.

Avastin® is manufactured by Genentech, Inc. (California, USA) and has become a standard therapy for metastatic colorectal cancer in 88 countries including Europe and US (as of July 2006), and its launch has been awaited in Japan. Avastin® was launched by Genentech in US and by F. Hoffmann-La Roche (Basel, Switzerland) in other countries.

Because of the very limited number of patients treated by Avastin® in domestic clinical trials, for a certain time period after launch, its use will 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 drug reactions, and which are willing to cooperate in all-case surveillance.
In preparation for the launch of Avastin®, Chugai is now investigating whether medical institutions which wanted to use it met the above conditions and conducting orientation sessions for those that did for arranging the all-case surveillance.
Following launch, Chugai will make every effort to collect and provide information on the proper use of Avastin® through its medical representatives, and Chugai's website will have a page devoted to Avastin® after its launch, where the following information is posted to provide the latest safety information.
(1) Outline of all-case surveillance
(2) Registration progress of all-case surveillance
(3) Adverse drug reactions in all-case surveillance

The launch of Avastin® in Japan provides a new option in the treatment of colorectal cancer, and securing the safety of patients who receive the drug and promoting its proper use of the top priorities.


[References]
Brand name: Avastin® for intravenous infusion 100mg/4mL
Avastin® for intravenous infusion 400mg/16mL
Generic name: Bevacizumab (genetical recombination)
Effect/Efficacy: 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.
Date of drug price standard listing: June 8, 2007
Date of launch: June 11, 2007
Expiration date: 2 years
Drug prices: Avastin® for intravenous infusion 100mg/4mL, JPY 50,291/vial
Avastin® for intravenous infusion 400mg/16mL, JPY 191,299/vial
Conditions for approval: 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® 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®."

About the Avastin® website:
Patients and their families should consult "Information for Patients and Medical Consumers" and healthcare professionals should consult "Information for Healthcare Professionals".

About the post marketing surveillance of Avastin® (post marketing survey of specific use)
The post marketing surveillance covering all patients who received Avastin® 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®
Avastin® 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 Vascular Endothelial Growth Factor (VEGF), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumor and its spread throughout the body (metastasis).

Avastin® is a registered trademark of Genentech, Inc. (USA)

Posted: June 2007


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