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Roche's Rozlytrek Nets Japanese Approval in NTRK-Positive Pan Cancer Indication

NEW YORK (GenomeWeb) – Japan’s Ministry of Health, Labor and Welfare approved Roche's entrectinib (Rozlytrek) for the treatment of adult and pediatric patients with NTRK fusion-positive, advanced recurrent solid tumors.

This is the first pan-cancer drug approved for NTRK-positive solid tumors by Japanese health regulators and has been granted Sakigake designation (akin to breakthrough designation in the US) and orphan drug designation. The drug is also under review for advanced non-small cell lung cancer patients with ROS1 fusions.

Regulators reviewed data from several studies, including the Phase II STARTRK-2, the Phase I STARTRK-1, and the Phase I/II STARTRK-NG study in pediatric patients. NTRK fusions occur in less than 1 percent of solid tumors, and as such, Roche's clinical trials enrolled patients across more than 150 clinical trial sites in 15 studies. Researchers enrolled patients with breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.

In the STARTRK-2 trial, entrectinib shrank tumors in nearly 57 percent of patients with 10 different types of NTRK-positive tumors, including those with cancers that had spread to the brain and spine. The STARTRK-1 trial evaluated the safety and tolerability of patients with NTRK1/2/3, ROS1 or ALK gene fusions in the US and South Korea. The STARTRK-NG study showed the ability of the drug to shrink tumors in children and adolescents with NTRK-positive tumors including those with central nervous system cancers.

Roche has submitted data from these same studies to the European Medicines Agency and the US Food and Drug Administration. The EMA has granted priority medicines designation and the FDA has grated priority review status to the drug for adult and pediatric patients with NTRK-positive advanced solid tumors without other options.

The FDA is slated to make a decision on the entrectinib NDA by Aug. 18. In the US, Loxo Oncology and Bayer's larotrectinib (Vitrakvi) was first to market last November as a pan-cancer drug for adult and pediatric patients with NTRK-positive tumors.

In a statement, Roche said it is working with subsidiary Foundation Medicine to advance a companion diagnostic in Japan to identify patients who are likely to benefit from entrectinib and harbor NTRK-fusions, which occur in less than 1 percent of solid tumors. The companion diagnostic is currently undergoing review, according to Roche.