Chugai Pharmaceutical Co to launch the BRAF inhibitor “Zelboraf tablet 240mg” 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. Thus, Zelboraf matches with the personalised 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 personalised 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 BRAFV600E mutation in the US 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.
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.
A drug risk management plan should be prepared and appropriately implemented. Because the number of patients in Japanese clinical trials is very limited, postmarketing drug use surveillance of all patients receiving Zelboraf should be conducted until data for a set number of patients are collected in order to identify the background characteristics of patients using Zelboraf, collect early data on the safety and efficacy of Zelboraf, and take necessary measures for appropriate use of Zelboraf.
For the first 500 patients who receive Zelboraf treatment, data will be collected, analysed and reported to the health authority. After collecting data for 500 cases, a review and decision will be made to determine whether a new surveillance or further safety measures should be considered. Results of this surveillance shall be reported to the public in future scientific meetings, as well as to the regulatory authorities.