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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: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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).
Lead Product(s): Tepotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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 tissue biopsy.
Lead Product(s): Tepotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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.
Lead Product(s): Tepotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: 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.
Lead Product(s): Tepotinib
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct 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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