Tokyo-based Chugai Pharmaceutical Co., Ltd. announced that it would launch bevacizumab (genetical recombination), a humanized anti-VEGF (Vascular endothelial growth factor) monoclonal antibody in Japan on June 11. Bevacizumab is a generic version of Avastin for intravenous infusion 100mg/4mL or 400mg/16mL. Earlier, on April 18, bevacizumab had obtained approval from the Japanese Ministry of Health, Labour and Welfare for the treatment of advanced or refractory colorectal cancer, if the patient is not the candidate for the curative operation. The medicine is also listed on National Health Insurance (NHI) drug reimbursement price list.
Avastin, which is manufactured by Genentech, Inc., has become a standard therapy for metastatic colorectal cancer in 88 countries including Europe and US. While avastin was launched in US by Genentech, F. Hoffmann-La Roche (Basel, Switzerland) launched it 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 with sufficient experience in cancer chemotherapy and the ability to provide effective emergency treatment to the adverse drug reactions. The medical institutions should also be 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 proposed conditions and conducting orientation sessions for those that did for arranging the all-case surveillance.
Pursuant to the launch of medicine, Chugai will make every effort to collect and provide information on the proper use of avastin through its medical representatives. Also, the company will dedicate one of its web pages to avastin to impart certain information, including:
■ Outline of all-case surveillance
■ Registration progress of all-case surveillance
■ 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.
Post marketing surveillance of avastin
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.
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).