Roche's Entrectinib Capsules Submitted for Priority Review in China for New Indication in Pediatric NTRK Fusion-Positive Solid Tumors

On May 24, the CDE website showed that Roche's entrectinib capsule (100mg and 200mg) is proposed to be included in the priority review, indicated for pediatric patients with NTRK fusion-positive locally advanced or metastatic solid tumors. This marketing application has been accepted by the CDE on May 22.

Entrectinib is a small-molecule inhibitor targeting ROS1/ALK/Trk developed by Roche. It was first approved for marketing in Japan in June 2019 for the treatment of patients with advanced or recurrent solid tumors positive for NTRK gene fusion. In August 2019, entrectinib was approved in the United States for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) positive for ROS1.

Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions are recognized oncogenic drivers expressed across multiple tumor types, including sarcomas, non-small cell lung cancer, and breast cancer, representing a potential therapeutic target for pan-cancer treatment. Studies have shown that the overall incidence of NTRK gene fusions in solid tumors is 0.3%, with variations in occurrence rates depending on tumor type and age.

According to Roche's 2022 annual report, the annual sales of Entrectinib Capsules (trade name: Rozlytrek) were 75 million Swiss francs (approximately 528 million yuan, +51%).

In July 2022, Entrectinib Capsules were approved for marketing in China under the trade name Rozlytrek. It is indicated for adult and pediatric patients aged 12 years and above with solid tumors who have been diagnosed with NTRK fusion genes by a fully validated testing method, excluding known acquired resistance mutations, and who have locally advanced or metastatic disease, or where surgical resection might lead to severe complications, as well as no satisfactory alternative treatment or prior treatment failure. In August of the same year, Rozlytrek received approval in China for its second indication, for the treatment of adult patients with ROS1-positive metastatic NSCLC.

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