Thursday, February 7, 2013

Chugai files Herceptin for post surgical Adjuvant treatment of HER2+ve breast cancer

Chugai has filed an NDA based on evidence in the public domain with Japan MHLW seeking approval for the additional dosage and administration of once a week  Herceptin for post surgical adjuvant  administration in breast cancer that over express HER2. 
In Japan, Herceptin is currently marketed for the indications of “breast cancer that overexpresses HER2,” and “advanced or recurrent gastric cancer over expressing HER2, not amenable to curative resection.

The filing was made based on the decision at the meeting of the Second Committee on New Drugs, Pharmaceutical Affairs and Food Sanitation Council, held on January 31, 2013, which confirmed that filing through the “NDA based on evidence in the public domain” was reasonable for this additional dosage and administration.

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