The NGS based CDx Human NTRK1/2/3 Genomic Alteration Test Kit to inform treatment decisions for larotrectinib developed by OrigiMed in cooperation with Bayer was granted the NMPA Special Review Procedure for Innovative Medical Devices in China
The Human NTRK1/2/3 Genomic Alteration Testing Kit has been developed to detect NTRK 1, 2 and 3 gene fusions in solid tumors. It is the first companion diagnostic developed specifically for larotrectinib in China and will help identify NTRK gene fusion positive patients for whom larotrectinib treatment may be appropriate.
Larotrectinib, a highly selective TRK inhibitor designed exclusively for the treatment of tumors with an NTRK gene fusion, is approved in more than 40 countries, including the US, EU countries and Japan for adult and pediatric patients with solid tumors an NTRK gene containing fusion. Additional filings in other markets, including China, are underway or planned.
The Human NTRK 1/2/3 Genomic Alteration Testing Kit is based on DNA- and RNA-based next-generation sequencing (NGS) and applies the innovative OriFusion, independently patented by OrigiMed as its core technology. Fusion candidates are identified by hybrid capture-based technology. Besides the known fusion, it can also effectively detect new fusions with high sensitivity and specificity.
Larotrectinib, a highly selective TRK inhibitor, is designed exclusively for the treatment of tumors that are NTRK1/2/3 gene fusion positive (TRK fusion cancer). The compound has demonstrated high response rates and sustained response in adults and children with TRK fusion cancer for three years, including response and a high disease control rate in central nervous system (CNS) tumors. It has the largest data set and longest follow-up data of all TRK inhibitors. The dataset of 218 patients was presented at the ASCO Annual Meeting 2021.
Larotrectinib is approved under the brand name Vitrakvi™ in more than 40 countries, including the US, EU countries, Japan and other markets worldwide, for solid tumors in children and adults harboring an NTRK gene fusion. Additional filings in other markets, including China, are underway or planned. The Human NTRK1/2/3 Genomic Alteration Detection Kit is an accompanying diagnostic test for larotrectinib in the treatment of adult and pediatric patients in China with solid tumors harboring an NTRK gene fusion once larotrectinib is approved for medical use.
About TRK Fusion Cancer
TRK fusion cancer is generally rare, affects both children and adults, and occurs in different frequencies in different tumor types. TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing an altered TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, activating a signaling cascade. These TRK fusion proteins act as oncogenic drivers that stimulate the spread and growth of the patient’s cancer, regardless of where it originates in the body.
OrigiMed is a precision medicine company focused on high-tech R&D with a global vision and knowledge transfer in cancer clinical practice. With a dedication to developing hundreds of cancer genomic tests, the company strives to provide every patient with comprehensive and accurate molecular information and help physicians with their precision medicine. OrigiMed aims to advance innovation in clinical cancer treatment in China. At OrigiMed, patients’ molecular changes are identified by the rigorously verified CGP and matched with approved targeted therapies, immunotherapies, and clinical trials. OrigiMed works closely with global and domestic biopharmaceutical companies to assist in the development and approval of new drugs. For more information, please visit: www.origimed.com