Among the 2 million newly diagnosed lung cancer cases in the world every year, about 85% of them are non-small cell lung cancer (NSCLC), of which 228000 are in the United States. Nearly 70% of NSCLC patients have genomic mutations. Metex14 (met gene exon 14 jump mutation) is a recognized tumor promoting factor, accounting for 3% - 4% of newly diagnosed advanced NSCLC cases (about 4000-5000 cases in the United States each year).
全球首款c-MET药物-Tepotinib
Tepotinib (EMD 1214063) is a highly selective oral c-met inhibitor developed by Merck KGaA in Germany.
In October 2019, it was approved to carry out clinical trials of advanced (locally advanced or metastatic) non-small cell lung cancer with met exon 14 mutation or met amplification.
On March 25, 2020, tepotinib (テポチニブテチニブテチニブ) was the first approved c-met inhibitor in the world.
On August 25, 2020, Merck KGaA of Germany announced that the FDA of the United States has accepted the new drug marketing application (NDA) of tepotinib, and granted it the priority review qualification. The indication is for patients with metastatic NSCLC with met exon 14 jump mutation. The new drug application is currently under review under the FDA real time Oncology Review (RTOR) pilot program, and it is expected that the new drug will be put on the market quickly.
国内在研的HGF/c-MET药物
国外进展较快的HGF/c-MET药物
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In addition to tepotinib of Merck, Novartis Inc 280 (capmatinib) was approved in the United States on May 6, 2020, and J & J jnj-61186372 (EGFR / CMET bispecific antibody) (previously approved by FDA as breakthrough therapy, EGFR exon 20 is inserted into mutated lung cancer) and so on.
Appendix: performance of major pharmaceutical products of Merck in fiscal year 2019
reference resources:
NMPA/CDE；
Drug melting circle data;
FDA/EMA；
Public disclosure of related companies;
FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations， https://www.prnewswire.com/news-releases/fda-accepts-filing-of-new-drug-application-for-tepotinib-for-the-treatment-of-patients-with-metastatic-nsclc-with-metex14-skipping-alterations-301117906.html ;
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review-pilot-program ;
Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med 2020 May 29; [e-pub]. ( https://doi.org/10.1056/NEJMoa2004407 )；
Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations； https://www.merckgroup.com/en/news/tepotinib-breakthrough-therapy-designation-11-09-2019.html ;
https://www.merckgroup.com/investors/reports-and-financials/earnings-materials/2019-q4/en/2019-Q4-Earnings-Presentation-EN.pdf , Germany Merck 2019ppt;
https://database.japic.or.jp/is/sp/pins/top.jsp;
https://www.merckgroup.com/jp-ja ;
https://www.merckgroup.com/jp-ja/press/merckserono/2018-serono/180327_ News_ Release_ tepotinib_ 180327_ JP.pdf ;
https://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_ iryou/iyakuhin/topics/tp150514-01.html；
http://pharmacist.hatenablog.com/entry/acknowledgment-20200226-1# テプ；
https://www.prnewswire.com/news-releases/novartis-announces-fda-approval-of-met-inhibitor-tabrecta-for-metastatic-non-small-cell-lung-cancer-with-metex14-301054461.html ; and so on.
