Launch of the anti-cancer agent / BRAF inhibitor “Zelboraf”

Posted: 26 February 2015 | Roche

Contribution to the treatment of melanoma by personalized healthcare…

Chugai Pharmaceutical Co., Ltd. [Ma in Office: Chuo-ku, Tokyo. Chairman & CEO: Osamu Nagayam a (hereafter, “Chugai”)] announced today that it will launch the BRAF inhibitor “Zelboraf ® Tablet 240mg” [generic name: vemurafenib] (hereafter, Zelboraf ® ) for the indication of “unresectable melanoma with BRAF mutation” on February 26, 2015. Zelboraf ® received a manufacturing and marketing approval on December 26, 2014 and was listed on the National Health Insurance (NHI) reimbursement price list on February 24, 2015.

Prior to administration of Zelboraf ® for patients with “unresectable melanoma with BRAF mutation,” it is essential to detect the BRAF mutation with the cobas ® 4800 BRAF V600 Mutation Test, launched by Roche Diagnostics K.K. [Main Office: Minato-ku, Tokyo. President & CEO: Makoto Ogasawara]. Thus, Zelboraf ® matches with the personalized healthcare strategy that selects an appropriate drug for patients expected to obtain the therapeutic effect by using biomarkers and/or diagnostic tools. It will enable to select the appropriate treatment for each patient before drug administration by personalized healthcare. This kit has been covered by insurance since February 1, 2015.

Zelboraf ®, created by Plexxikon, a member of the Daiichi Sankyo Group, is an oral, small molecule BRAF kinase inhibitor that is designed to selectively inhibit a cancer-driving mutated form of the BRAF protein. Zelboraf ® was approved for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E mutation in the U.S. in 2011 and in Europe in 2012.

It is reported that each year 1 ,300 to 1,400 patients (Globocan 2012) are newly diagnosed with melanoma (all stages) in Japan, and the number has been growing . Of these patients, approximately 30 to 40% have the BRAF gene mutation1,2.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will promote appropriate use of Zelboraf ® in order to contribute optimally to the treatment of patients with “unresectable melanoma with BRAF mutation,” a disease with poor prognosis and with high unmet medical need, by providing a new therapeutic option.

  1. Ashida A., et al.: J Dermat ol Sci. 2012 Jun; 66 (3): 240-242 .
  2. Yamazaki N., et al.: Melanoma Res. 2015 Feb; 25 (1): 9-14. 

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