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    [{"orgOrder":0,"company":"EMD Serono","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New England Journal of Medicine Publishes Primary Analysis of VISION Data for Tepotinib in Advanced NSCLC with METex14 Skipping Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"EMD Serono","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Filing of NDA for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Merck & Co","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Filing of NDA for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Merck & Co","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency Validates Application for Merck's Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Merck & Co","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"TEPMETKO\u00ae (Tepotinib) Receives Positive CHMP Opinion for Patients with Advanced NSCLC with METex14 Skipping Alterations","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]

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              Merck & Co

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              TEPMETKO® (Tepotinib) Receives Positive CHMP Opinion for Patients with Advanced NSCLC with METex14 Skipping Alterations

              Details:

              CHMP positive opinion is based on results from the pivotal Phase II VISION study evaluating TEPMETKO (Tepotinib) as a once-daily oral monotherapy treatment for patients with advanced NSCLC with METex14 skipping alterations.

              Lead Product(s): Tepotinib

              Therapeutic Area: Oncology Product Name: Tepmetko

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 17, 2021

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              Merck & Co

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              European Medicines Agency Validates Application for Merck's Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations

              Details:

              The application to EMA is based on results from the pivotal Phase II VISION study evaluating tepotinib as monotherapy in patients with advanced NSCLC with METex14 skipping alterations, prospectively assessed by liquid biopsy (LBx) or tissue biopsy (TBx).

              Lead Product(s): Tepotinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 26, 2020

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              EMD Serono

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              FDA Accepts Filing of NDA for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations

              Details:

              The application is based on results from the pivotal ongoing, single-arm Phase II VISION study evaluating tepotinib as monotherapy in patients with advanced NSCLC with MET exon 14 (METex14) skipping alterations prospectively assessed by liquid and/or tissue biopsy.

              Lead Product(s): Tepotinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 25, 2020

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              Merck & Co

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              FDA Accepts Filing of NDA for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations

              Details:

              US FDA has accepted and granted Priority Review to the new drug application for orally-dosed tepotinib* for the treatment of adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to METex14 skipping.

              Lead Product(s): Tepotinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 25, 2020

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              EMD Serono

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              New England Journal of Medicine Publishes Primary Analysis of VISION Data for Tepotinib in Advanced NSCLC with METex14 Skipping Alterations

              Details:

              First publication of primary analysis shows robust and durable clinical response in patients with advanced non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations; data also presented during ASCO 2020.

              Lead Product(s): Tepotinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 29, 2020

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