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.
Brand Name : Tepmetko
Molecule Type : Small molecule
Upfront Cash : Not Applicable
December 17, 2021
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).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 26, 2020
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 tis...
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 25, 2020
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 25, 2020
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.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 29, 2020
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