Chugai Pharmaceutical Co., Ltd. announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on May 25, 2023, for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for an anti-cancer agent/MET inhibitor, Tabrecta (generic name: capmatinib hydrochloride hydrate) of Novartis Pharma K.K. (Novartis), which is approved for the treatment of MET exon 14 skipping mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). With this approval, patients with advanced NSCLC who may be eligible for treatment with capmatinib can be identified through both tissue-based and liquid-based comprehensive genomic profiling (CGP) tests.
FDA approves capmatinib for metastatic non-small cell lung cancer
Novartis has announced that the European Commission (EC) has approved Tabrecta – also known as capmatinib – as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC).
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) has issued a positive opinion that recommends granting marketing authorization for capmatinib (Tabrecta®) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
A committee of the European Medicines Agency (EMA) recommended the approval of Novartis' (NYSE:NVS) Tabrecta to treat certain patients with advanced non-small cell lung cancer (NSCLC).
-Incyte (Nasdaq: INCY) today announced that data from the Novartis pivotal Phase 2 GEOMETRY mono-1 study demonstrating that treatment with Tabrecta™ (capmatinib) resulted in positive overall response rates (ORR) with durable responses 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) have been published in The New England Journal of Medicine.1
Tabrectaâ„¢ (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14)
Merck KGaA could be looking at an early 2021 approval for its MET inhibitor tepotinib in lung cancer from the FDA after the US regulator started a priority review of the drug, but could still be beaten to market by a rival drug.