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Tabrecta FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved May 6, 2020)
Brand name: Tabrecta
Generic name: capmatinib
Dosage form: Tablets
Company: Novartis Pharmaceuticals Corporation
Treatment for: Non-Small Cell Lung Cancer

Tabrecta (capmatinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

Development timeline for Tabrecta

May  6, 2020Approval FDA Approves Tabrecta (capmatinib) for Metastatic Non-Small Cell Lung Cancer with METex14
Feb 11, 2020Novartis Announces MET Inhibitor Capmatinib (INC280), the First Potential Treatment for METex14 Mutated Advanced Non-Small Cell Lung Cancer, Granted Priority FDA Review
Sep  6, 2019Novartis Investigational Lung Cancer Therapy Capmatinib (INC280) Granted FDA Breakthrough Therapy Designation for Patients with MET-Mutated Advanced Non-Small Cell Lung Cancer
Jun  3, 2019Novartis Shows Growing Strength in Lung Cancer Innovation with New Capmatinib Investigational Data and Novel Canakinumab Clinical Trials
Oct 19, 2018Novartis phase II GEOMETRY mono-1 trial of investigational medicine capmatinib (INC280) shows positive results in patients with MET mutated advanced NSCLC
Oct 19, 2018Phase 2 GEOMETRY mono-1 Trial of Investigational Medicine Capmatinib Shows Positive Results in Patients with MET-mutated Advanced NSCLC

Further information

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