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Details:
Tabrecta is a kinase inhibitor that targets MET. European Commission approved Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer harboring alterations leading to mesenchymal-epithelial-transition factor gene exon 14 (METex14) skipping who require systemic therapy.
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: Tabrecta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 22, 2022
Details:
Positive opinion for Tabrecta from CHMP based on Phase 2 GEOMETRY mono-1 study showing overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with NSCLC harboring alterations leading to MET exon 14 skipping.
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: Tabrecta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Details:
Opinion based on Phase II GEOMETRY mono-1 study for Tabrecta showing an overall response rate of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with advanced NSCLC harboring alterations leading to MET exon 14 skipping.
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: Tabrecta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Incyte Corporation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 22, 2022
Details:
TABRECTA® is the first therapy approved by the FDA for adult patients with metastatic NSCLC whose tumors have an alteration that leads to METex14.
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: Tabrecta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2021
Details:
The New England Journal of Medicine show treatment with Tabrecta™ resulted in positive overall response rates (ORR) among adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to skipping of MET exon 14 (METex14).
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: Tabrecta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated non-small cell lung cancer (NSCLC) patients with MET exon 14 skipping (METex14) respectively.
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: Tabrecta
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
Details:
Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer. There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC.
Lead Product(s): Capmatinib Hydrochloride
Therapeutic Area: Oncology Product Name: INC280
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 February 11, 2020
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