Chugai Pharmaceutical Co, Ltd announced that Chugai has obtained approval for the additional indication of its oral fluoropyrimidine (5-FU) anti-cancer agent capecitabine [Product name: 'Xeloda tablets 300' (hereafter, 'Xeloda')], in combination with oxaliplatin, in the treatment of patients with 'advanced or refractory colorectal cancer who are not candidates for curative surgery'. Approval was received on September 18, 2009 from the Ministry of Health, Labour and Welfare (hereafter, MHLW).

Chugai also obtained an approval for additional dosage and administration of its anti-VEGF human monoclonal antibody bevacizumab (genetical recombination) [Product name: 'Avastin Injection 100 mg/4 mL and 400 mg/16 mL' (hereafter, Avastin)] on the same day.

The new approved combination therapy with Xeloda and oxaliplatin (a regimen called Xelox) is one of the standard treatments outside Japan for patients with advanced or refractory colorectal cancer considered unsuitable for the curative operation. With oral Xeloda, Xelox enables a once-every-three-week outpatient treatment, which reduces burdens associated with chemotherapy treatment for patients and healthcare providers.

Chugai submitted to MHLW the results from multiple overseas pivotal phase-III studies and a domestic phase-I/II study with the application for approval in February 2008. The overseas studies (NO16966 and NO16967) showed that Xelox was comparable to a current standard treatment, the combination therapy with 5-FU/LV and oxaliplatin (a regimen called Folfox), in terms of progression-free survival, overall survival and adverse event profile. NO16966 study also showed that Xelox in combination with Avastin significantly improved progression-free survival, the primary endpoint of the study, compared with Xelox alone. The domestic phase-I/II study showed that Xelox in combination with Avastin was equally tolerated by Japanese patients compared with non-Japanese patients, with a response rate of 71.9 per cemt based on the Response Evaluation Criteria in Solid Tumours (RECIST).

Chugai positions Oncology as one of its key therapeutic areas. Through development of new treatment options, Chugai will continue its effort to contribute to cancer treatment.

Xeloda was initially launched in the Japanese market as a treatment for inoperable or recurrent breast cancer in June 2003 by Chugai, and obtained additional approval for the overseas dosage and administration in breast cancer and a new indication of postoperative adjuvant chemotherapy for colon cancer on December 12, 2007.

Avastin was approved as a treatment for metastatic colorectal cancer in the US in February 2004 and is positioned as a standard treatment in the guidelines.

Oxaliplatin is globally positioned as a standard treatment for advanced or recurrent colorectal cancer and postoperative adjuvant chemotherapy for colon cancer.