ZorGene and Bayer's Larotrectinib Companion Diagnostic Receives Innovation Medical Device Special Review Approval in China
VCBeat (WeChat ID: vcbeat) has learned that today, OrigiMed, a leading domestic company in precision oncology, announced that its Human NTRK1/2/3 Gene Variation Detection Kit (Reversible Terminator Sequencing Method) has been granted approval for the “Special Review Procedure for Innovative Medical Devices” by the Center for Medical Device Evaluation of the National Medical Products Administration. This product was co-developed by OrigiMed and Bayer.
It is understood that the Human NTRK1/2/3 Gene Variant Detection Kit (Reversible Terminator Sequencing Method), based on next-generation sequencing technology, will be used for the detection of NTRK1, NTRK2, and NTRK3 gene fusion variants in solid tumors. This is also China’s first companion diagnostic kit for Larotrectinib, which will help identify cancer patients positive for NTRK gene fusions and potentially enable them to achieve clinical benefits through Larotrectinib treatment.
Larotrectinib is a highly selective TRK inhibitor designed for the treatment of patients with tumors harboring NTRK gene fusions. It has currently been approved in more than 40 countries and regions, including the United States, the European Union, and Japan, for the treatment of adult and pediatric patients with solid tumors carrying NTRK gene fusions. Currently, its New Drug Application (NDA) has been accepted by the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA), while applications in other regions are ongoing or planned.
Human NTRK1/2/3 Gene Variant Detection Kit (Reversible Terminator Sequencing Method): The core technology is derived from OriFusion, an innovative patented technology independently developed by OrigiMed. By analyzing candidate fusions through hybridization capture technology, it achieves high sensitivity and specificity in detecting both known and novel fusions, thereby effectively improving the detection rate.
Larotrectinib, a highly selective TRK inhibitor, is specifically designed for the treatment of patients with tumors harboring NTRK1/2/3 gene fusions (TRK fusion cancers). Over three years, this compound has demonstrated high response rates and durable responses in adult and pediatric patients with TRK fusion cancers, including responses in central nervous system (CNS) tumors and high disease control rates. Larotrectinib boasts the largest dataset and the longest follow-up data among all TRK inhibitors. The dataset comprising 159 patients was published in The Lancet Oncology, and updated results were presented at the 2021 ASCO Annual Meeting.
Larotrectinib is the first oral TRK inhibitor specifically designed for cancer patients with NTRK gene fusions. This compound has demonstrated high response rates in adults and children with TRK fusion-positive cancers, including central nervous system (CNS) cancers, with durable responses lasting over four years.
Larotrectinib, marketed under the brand name Vitrakvi™, has currently been approved in more than 40 countries and regions worldwide, including the United States, the European Union, and the United Kingdom, for the treatment of solid tumors in pediatric and adult patients with NTRK gene fusions. Applications in other markets, including China, are ongoing or planned. The Human NTRK1/2/3 Gene Variation Detection Kit (Reversible Terminator Sequencing Method) is intended to serve as the companion diagnostic kit for patients with solid tumors harboring NTRK gene fusions following the future approval of Larotrectinib in China.
TRK fusion cancers are rare malignancies that are not restricted to specific tissue types and can arise in various parts of the body. The prevalence of TRK fusion cancers varies significantly across multiple adult and pediatric solid tumors. These cancers result from the fusion of an NTRK gene with an unrelated gene, leading to the production of abnormal TRK proteins. Known as TRK fusion proteins, these aberrant proteins exhibit constitutive activation, resulting in sustained overactivation of downstream cell signaling pathways. Regardless of the tumor’s primary site, TRK fusion proteins promote tumor growth and dissemination, thereby driving the development of TRK fusion cancers.
OrigiMed is a precision medicine company focused on the research and development of international high-tech solutions and their clinical translation in oncology. It is committed to advancing clinical testing for hundreds of cancer-related genes, providing comprehensive and accurate molecular-level information for each patient to support physicians in delivering precision therapy and driving innovation in clinical cancer care in China. By offering rigorously validated comprehensive genomic profiling, OrigiMed identifies molecular alterations in patients’ tumors and matches them with relevant targeted therapies, immunotherapies, and clinical trials. Currently, OrigiMed has established deep collaborations with numerous biopharmaceutical companies both in China and abroad, supporting clinical trials and new drug development.