DARMSTADT, Germany, November 26, 2020 / PRNewswire / – Merck, a leading science and technology company, today announced that the European Pharmacological Agency (EMA) has validated for review, tepotinib for the treatment of adult patients with advanced non-small cell cancer (NSCLC). Application for mesenchymal-epithelial infection factor gene (met) Exxon 14 ()metex14) skipping change. With this verification, the application is complete, and the EMA will now begin the review process.
Tepotinib is a highly selective oral MET inhibitor that is administered once daily.1 Application to EMA is based on the results of a decisive phase II approach study (NCT02864992) evaluating tepotinib as monotherapy in patients with advanced NSCLC metex14 skipping changes, potentially assessed by liquid biopsy or tissue biopsy. In an ongoing study, the patient population is commonly referred to as elderly, with an average age of 74.0 years, and when diagnosed with a specific clinical disease with NSCLC metex14 skipping change. Data from primary analysis of visual studies were published in The New England Journal of Medicine (NEJM) On May 29, 2020.2
Lung cancer is estimated to be the second most common cancer. Europe, And the leading cause of cancer-related mortality, accounted for 388,000 deaths in 2018.3 metex14 skipping occurs in approximately 3 to 4% of cases of NSCLC and is characterized by aggressive tumor behavior and poor clinical prognosis.4 Currently, there are no treatments available. Europe For patients with advanced NSCLC harboring metex14 skipping change.
Tepotinib becomes the first oral mate inhibitor indicated for the treatment of advanced NSCLC harboring met Gene change worldwide with its approval to obtain regulatory approval Japan In March 2020 Through the SAKIGAKE program. Recently, the FDA granted orphan drug designation (ODD) to tepotinib and the FDA is reviewing applications under priority review and through the Real-Time Oncology Review Pilot Program.
Tepotinib is an oral inhibitor that inhibits oncogenic met Receptor signaling due to met (Gene) transformation. In-house was discovered and developed in Merck, it has a very selective mechanism of action, With the potential to improve outcomes in invasive tumors that have poor prognosis and disturb these specific changes.1
Additional diagnostic tests: Tepotinib is also being investigated in combination with osimertinib in II II INSIGHT 2 met Enlarged, advanced or metastatic NSCLC is difficult to activate EGFR Mutations that have proceeded after first-line treatment with osimertinib, and immunity due to anti-EGFR antibody targeting therapy in studies of second-stage paralysis in combination with sextimab in RA / BRF wild-type left-sided metastatic colorectal patients. Patients acquired met Amplification.
- Leaf F, et al. Clin Cancer Race. 2013; 19: 2941–2951.
- Paik PK et al. Tapotinib in non-small-cell lung cancer met Exon 14 skipping mutations. N angle j med 2020 May 29; [e-pub]. (https://doi.org/10.1056/NEJMoa2004407)
- Farley J, et al. Eur J Cancer. 2018; 103: 356–387.
- Reungavatwana T, et al. lung cancer. 2017; 103: 27–37.
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