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Merck’s MET inhibitor tepotinib gains positive opinion from MHRA pharmatimes
July 16, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion for Merck’s tepotinib for the treatment of advanced non-small cell lung cancer (NSCLC) with METex14 skipping alterations.
FDA Grants Accelerated Approval to Tepotinib for Metastatic NSCLC americanpharmaceuticalreview
February 09, 2021
The U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping ...
EMA Validates Application for Tepotinib for Advanced NSCLC americanpharmaceuticalreview
December 14, 2020
Merck announced the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene ...
EU to review Merck's targeted lung cancer drug pharmatimes
November 30, 2020
European regulators will review Merck's tepotinib for a specific type of lung cancer, having validated the drug's marketing application.
EMA validates Merck’s application to review tepotinib for lung cancer pharmaceutical-technology
November 30, 2020
The European Medicines Agency (EMA) has validated Merck’s application for reviewing tepotinib as a treatment for adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 ...
European Medicines Agency Validates Application for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations prnasia
November 27, 2020
Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) ...
FDA Accepts NDA Filing for Tepotinib for Metastatic NSCLC with METex14 Skipping Alterations americanpharmaceuticalreview
August 26, 2020
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, has announced the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for ...
Metastatic NSCLC therapy, tepotinib, given Breakthrough Designation europeanpharmaceuticalreview
September 12, 2019
Tepotinib, an investigational therapy for patients with metastatic non-small cell lung cancer has been given Breakthrough Therapy Designation.