Friday, June 14, 2013

Herceptin approved in Japan as an adjuvant treatment post surgery in HER2+vE breast cancer

Chugai has received Japan MHLW approval on June 14, 2013 for Herceptin as once a week administration for postoperative adjuvant chemotherapy in breast cancer that overexpresses HER2. In Japan, Herceptin is currently marketed for the indications of first line metastatic HER2+ve breast cancer and advanced or recurrent HER2+ve gastric cancer.


The approval is a result of the  evaluation by the 14th Review Committee on Unapproved Drugs and Indications with High Medical Needs held on December 26, 2012, an application based on evidence in the public domain. The decision at the meeting of the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council, held on January 31, 2013, confirmed that filing through the “application based on evidence in the public domain” was reasonable for this dosage and administration. Thereby, Chugai filed an “application based on evidence in the public domain” for the additional dosage and administration on February 7, 2013, and obtained approval by the MHLW.

The “Review Committee on Unapproved Drugs and Indications with High Medical Needs” was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in western countries but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of NDA based on evidence in the public domain” and investigating the need for studies that should be additionally conducted.
 





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