Data from the World Health Organization (WHO) shows that approximately 400,000 children worldwide are diagnosed with cancer each year.[1]. Unlike adult tumors, pediatric malignant tumors mainly originate from mesenchymal tissues of the non-epithelial system, such as sarcomas,Blastoma,Brain TumorMostly.Compared with adult antineoplastic drugs, there is a more urgent clinical demand for pediatric oncology medications, especiallyAre high-risk and recurrent refractory pediatric patients who usually face challenges such as lack of available drugs and suboptimal existing treatment options.

NTRKGene fusion is a clear oncogenic driver and is expressed in multiple tumor types, including sarcoma, non-small cell lung cancer, breast cancer, etc., making it a potential therapeutic target for pan-cancer. In pediatric tumors,NTRKThe incidence of gene fusion is relatively higher compared to adults.

Entrectinib is precisely aTRK/ROS1 Tyrosine Kinase Inhibitor, capable of crossing the blood-brain barrier. This product has previouslySuccessively in the United States, the European Union,JapanListed in places like ..., used for treatmentNTRKPatients with fusion gene-positive solid tumors, as well as those with ROS1-positive advanced non-small cell lung cancer. In China, this product has been previously approved.Treatment for 12 years and aboveNTRKFusion-positive solid tumors, andPatients with ROS1-positive non-small cell lung cancer.

This timeEntrectinibTinibThe new indication approved in China is for infants aged one month and above.NTRKPediatric solid tumor patients. According to Roche's public data, the phase 1/2 STARTRK-NG study enrolledTargetedNTRK1/2/3、ROS1OrALKPediatric and adolescent patients with extracranial solid tumors or primary CNS tumors harboring fusion genes，A total of 35 patients received entrectinib treatment and underwent efficacy evaluation, with a median age of 7 years (4.9 months to 20 years).Trial data show that 17 cases were positive for gene fusion.Objective Response Rate (ORR) was 76% (13/17), where the ORR was 70% (7/10) in patients with primary CNS tumors and 86% (6/7) in patients with extracranial solid tumors.

Head of Roche Global Pharma Development China CenterDr. Li XinIndicates,We are very pleased that the National Medical Products Administration of China has quickly approvedEntrectinib Capsules`, greatly alleviated`NTRKIntegration of personalized and precise diagnosis and treatment needs for pediatric solid tumor patients.In the future, Roche will continue to collaborate with various partners to optimize treatment options, promote standardized diagnosis and treatment for rare targets across tumors, and bring hope of a cure to more pediatric solid tumor patients.

President of Roche Pharmaceuticals ChinaMs. Bian XinIndicates,This timeEntrectinib CapsulesThe approval of the new indication can bring innovative personalized medical solutions to more Chinese children with solid tumors, helping achieve greater patient benefits with less social cost.Childhood cancer patients are a group that cannot be overlooked,Entrectinib CapsulesNew indications have achieved encouraging results in relevant studies.

References:

[1] Roche's Rozlytrek® Receives Another Approval in China, Bringing New Hope for Pediatric Solid Tumor Treatment. Retrieved Feb 8, 2024, from https://mp.weixin.qq.com/s/B6YNBOkjnGZJWiaq9Npz5g

[2]World Health Organization. Global status report on noncommunicable diseases 2020.