Chugai Pharmaceutical Co., Ltd., one of Japan’s leading research-based pharmaceutical companies with strengths in biotechnology products, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for “unresectable melanoma with BRAF mutation,” for an anti-cancer agent, BRAF inhibitor, vemurafenib tablets (Zelboraf tablet 240mg.

Also, Roche Diagnostics K.K. obtained approval from the MHLW for in vitro diagnostics to detect the BRAF mutation, “cobas 4800 BRAF V600 Mutation Test,” as a companion diagnostics for Zelboraf on December 2, 2014.

It is necessary to detect BRAF mutation with cobas 4800 BRAF V600 Mutation Test before use of Zelboraf for patients with unresectable melanoma with BRAF mutation. As just described, medical approach to select an appropriate therapy for each patient before administration of a drug is called personalized healthcare. It enables to avoid a treatment unlikely to show efficacy. Furthermore, since a treatment unlikely to be effective is not given, personalized healthcare increase the benefit in terms of medical economics.

It is reported that each year 1,300 to 1,400 patients (Globocan 2012) in Japan are newly diagnosed as malignant melanoma (all stages), and the number has been growing. Of these patients, 26.7 to 41.8% have the BRAF gene mutation).

Chugai and Roche Diagnostics, members of the Roche Group and pioneers in personalized healthcare, are sure that Zelboraf and cobas 4800 BRAF V600 Mutation Test can contribute to the treatment of “unresectable melanoma with BRAF mutation,” a disease with poor prognosis and with high unmet medical needs. We will continue to dedicate ourselves to providing treatment options to suit individual patients.