Japan has recently become the first country to approve Roche/Chugai’s personalized medicine Rozlytrek (entrectinib) for adult and pediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive advanced recurrent solid tumors. Against this back drop, precision medicine is set to make steady headway in Japan, says GlobalData, a leading data and analytics company.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “Japan continues to be a ‘hotspot’ for precision medicine in Asia driven by speedier approvals of targeted therapies and the supporting companion diagnostics (CDx) as part of the Japanese Ministry of Health, Labour and Welfare (MHLW)’s ambitious precision medicine program.”

Heather Leach, Pharma Director of Oncology at GlobalData, says: “There is a large increase in the development of agents that fall under precision medicine. Drug developers are now studying biomarkers for patient targeting in nearly all solid tumor types, and GlobalData expects this trend to continue in the foreseeable future.”

GlobalData’s report, ‘Biomarkers and Companion Diagnostics in Oncology, reveals that so far more than 10 CDx have been approved in Japan. The MHLW’s CDx technical guidance emphasizes on co-development of CDx for reimbursement. Recently, MHLW approved FoundationOne CDx Cancer Genomic Profile as CDx for Rozlytrek.

Sahu adds: “Precision medicine necessitates the identification of target population through the use of diagnostic tests, which are objective, quick and accurate. Improved selection of the target patient population facilitated by CDx aids physicians in matching the patient to the right therapy, thereby mitigating healthcare costs and adverse effects due to unnecessary and inappropriate treatments.”

Japan is at the forefront of the research on precision medicine with numerous government supported programs including but not limited to The BioBank Japan Project, which was initiated in 2003, and the latest nationally sponsored and reimbursed next-generation sequencing (NGS) testing. Japan also established The Pharma SNP Consortium and Japan PGx Data Science Consortium (JPDSC) to study pharmacogenomics, which can be beneficial in the development of precision medicines.

Rozlytrek is the second tumor-agnostic drug to be approved in Japan, after Merck’s anti-PD-1 drug, Keytruda, which was approved by the MHLW in December 2018. Tumor agnostic drugs are a subclass of precision medicines designed to treat solid tumors based on a genetic marker rather than where they occur in the body. In February 2019, MHLW approved the MSI-IVD CDx Kit for Keytruda. Roche/Chugai filed an application for approval of Rozlytrek for the treatment of ROS1 fusion gene positive NSCLC in March 2019 in Japan.

Sahu and Leach conclude: “Approval of precision medicines, such as Keytruda and Rozlytrek, in quick succession and the subsequent approval of the corresponding CDx demonstrate Japan’s commitment towards the precision medicine program. This precedent is likely to encourage the further lineup of precision drugs, targeting various biomarkers, particularly in cancer progress towards approval in Japan.”