Singapore, Sep 7, 2010: Japan's Chugai Pharmaceutical has filed a new drug application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW), seeking approval for Xeloda. The compound indicates “advanced or refractory gastric cancer in patients who are not candidates for curative surgery”, for the anti-cancer agent capecitabine.

 

As a result of the review committee held in April 2010, the MHLW requested that Chugai develop Xeloda for the indication of “unresectable advanced or recurrent gastric cancer.” Then on Aug 3, 2010, the review committee concluded that an “NDA based on evidence in the public domain” is applicable when filing for this indication.

This 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 Aug 30, which confirmed that filing through the “NDA based on evidence in the public domain” was reasonable for this indication.

 

In Japan, Xeloda is currently marketed for the indications of “inoperable or recurrent breast cancer,” “postoperative adjuvant chemotherapy for colon cancer,” and “advanced or refractory colorectal cancer in patients who are not candidates for curative surgery.”

 

Xeloda has already been approved in many European and Asian countries for the indication of “advanced gastric cancer” and has been used as one of the standard therapies. Chugai will make efforts toward an early approval so that Xeloda can be provided to patients as a treatment for “advanced or refractory gastric cancer who are not candidates for curative surgery,” based on high unmet medical needs.