▎Edited by the WuXi AppTec content teamTodayDay (December 8), The official website of China's National Medical Products Administration (NMPA) has recently announced that the 5.1 class new drug tepotinib hydrochloride tablets submitted by Merck KGaA has been officially approved.. Public information shows,TepotinibIt is an oral MET inhibitor that has previously been approved for marketing in Japan and the United States for the treatment of patients withMETExon14（METex14) Patients with non-small cell lung cancer (NSCLC) who have leapt。
Screenshot source:NMPA Official Website
Tepotinib (English trade name: Tepmetko) is a highly selective oral MET inhibitor developed by Merck KGaA, designed to inhibitMETOncogenic MET Receptor Signaling Caused by Gene Mutations, includingMETex14Jump Change,MET Amplification or MET protein overexpression。TepotinibDesigned to improve the prognosis of aggressive tumors with poor prognosis and these specific mutations, the intended indications under development includeNSCLC、Hepatocellular carcinoma, colorectal cancer and theirIt exists.METMutant Solid Tumors。In China, tepotinib previouslyLanded in Lecheng, Hainan in December 2021, and has been included in the "Lecheng Global Special Drug Insurance" and "Beijing Inclusive Health Insurance", thereby providingMETex14Targeted treatment options for lung cancer patients with jumping mutations. In March 2022, the product submitted a new drug marketing application in China and was accepted.According to the China Drug Clinical Trial Registration and Information Disclosure Platform, tepotinib has previously completed twoPhase 1b/2 trial,Respectively forHepatocellular CarcinomaAsian Subjects andMET-positive advanced NSCLCPatient. At present, the product is being developedOneTreatment hasMETExon14Jumping mutation orMETAmplification NSCLCPhase 2 Trial, andA project inHasEGFRActivating mutations and acquired resistance to osimertinib afterMETAdvanced or Metastatic NSCLC with AmplificationPhase 2 Two-Arm Study Conducted in Patients。
Overseas,Tepotinib has been granted Fast Track and Orphan Drug designations by Japan's Ministry of Health, Labour and Welfare (MHLW), as well as Breakthrough Therapy designation and Priority Review status by the U.S. FDA.In March 2020, tepotinib in JapanApprovedFor treatmentMETex14Patients with unresectable, advanced, or recurrent NSCLC who are leaping.February 2021, FDAAccelerated ApprovalTepotinib Oral Launch, used to treat carriers ofMETex14Adult patients with metastatic non-small cell lung cancer with jumping mutations.Tepotinib received marketing approval in Japan and the United States based on aA pivotal Phase 2 clinical trial named VISIONThe support. In this study, a total of 152 carriersMETex14Patients with advanced or metastatic NSCLC with skipping mutations received monotherapy with tepotinib. The trial results showed,Tepotinib Achieves 43% Overall Response Rate in Both Treatment-Naïve and Previously Treated PatientsThe median duration of response (DOR) was 10.8 months for treatment-naïve patients and 11.1 months for previously treated patients.67% of treatment-naïve patients and 75% of previously treated patients had a duration of response lasting more than 6 months, while 30% of treatment-naïve patients and 50% of previously treated patients had a duration of response lasting more than 9 months.Non-small cell lung cancer is the most common type of lung cancer, accounting for approximately 85% of all lung cancer patients.METIt is one of the driver genes of cancer, and in NSCLC, it carriesMETMutated cases account for about 3% to 4% of the total.。These patients are generally older and often have a poor prognosis.Moreover, the MET signaling pathway also plays a significant role in driving lung cancer to develop resistance to other targeted therapies.It is hoped that the approval of tepotinib in China will bring new treatment options and clinical benefits to more cancer patients.
[1] December 08, 2023, Drug Approval Certificate Delivery Information Released on the Official Website of the China National Medical Products Administration. Retrieved Dec 08, 2023, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20231208152050137.html[2] TEPMETKO® (Tepotinib) Approved in Japan for Advanced NSCLC with METex14 Skipping Alterations, Retrieved March 25, 2020, from https://www.prnewswire.com/news-releases/tepmetko-tepotinib-approved-in-japan-for-advanced-nsclc-with-metex14-skipping-alterations-301029496.html[3] FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations. Retrieved February 3, 2021, from https://www.prnewswire.com/news-releases/fda-approves-tepmetko-as-the-first-and-only-once-daily-oral-met-inhibitor-for-patients-with-metastatic-nsclc-with-metex14-skipping-alterations-301221542.htmlThis article is from the content team of WuXi AppTec. Individuals are welcome to share it on their WeChat Moments. Unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For reprint authorization, please leave a message on the "Pharma Observer" WeChat Official Account to contact us. For other cooperation inquiries, please contact wuxi_media@wuxiapptec.com.
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