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Roche’s Rozlytrek approved for the NTRK fusion-positive advanced recurrent solid tumors in Japan

Rozlytrek (entrectinib) was the first tumor-agnostic medicine approved for the treatment of NTRK fusion-positive advanced recurrent solid tumors in Japan. The product was approved by the Ministry of Health, Labour and Welfare in Japan indicated for adult and pediatric patients with neurotrophic tyrosine receptor kinase fusion-positive, advanced recurrent solid tumors. The drug was approved for solid cancers including pancreatic, thyroid, salivary gland, breast, colorectal, and lung cancers.


The approval was based on pivotal Phase II STARTRK-2 study, Phase I STARTRK-1 and Phase I ALKA-372-001, and Phase I/II STARTRK-NG trials. In Phase II STARTRK-2 study, the median duration of response 10.4 months.


The most common adverse events reported are diarrhea, dizziness, fatigue, swelling (edema), weight increase, anemia, blood creatinine increase, shortness of breath (dyspnea), and nausea.


Patients eligible for the treatment are diagnosed by testing biomarker testing for NTRK gene fusions.


The product is also under review for the treatment of patients suffering from ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer in Japan.