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.
Novartis Pharma K.K. (“Novartis Pharma”) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta™ (capmatinib, formerly INC280), an oral MET inhibitor for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.
Chugai Pharmaceutical announced that it obtained an approval from the Ministry of Health, Labour and Welfare (MHLW) for expanded use of the genomic mutation analysis programme, FoundationOne CDx Cancer Genomic Profile as a companion diagnostic of the Novartis’ investigational MET inhibitor, capmatinib (INC280) for the treatment of unresectable advanced and/or metastatic non-small cell lung cancer (NSCLC) with that leads to MET exon 14 skipping (METex14).
Before the COVID-19 pandemic, Novartis was already digitizing its sales and marketing. But the outbreak—coupled with a recent OK for targeted lung cancer med Tabrecta—has the company hitting fast-forward.
The US Food and Drug Administration (FDA) on Wednesday granted accelerated approval to Novartis Pharmaceuticals’ Tabrecta (capmatinib) as the first targeted therapy for adults with metastatic non-small cell lung cancer (NSCLC) who have mutations that drive mesenchymal-epithelial transition (MET) exon 14 skipping. The drug inhibits MET tyrosine kinase, an enzyme associated with cancer cell growth and metastasis.
The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta (capmatinib) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.
The FDA has awarded marketing authorisation to Novartis for the Oral MET inhibitor Tabrecta (capmatinib) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have a mutation that leads to MET exon 14 skipping (METex14), regardless of whether they have previously received any type of treatment.
Over a decade after Novartis promised Incyte up-to $1.1 billion for a pair of early stage drugs, the second of the two has crossed the finish line.
Novartis and Merck KGaA have been racing their targeted lung cancer drugs to markets around the world, but it’s the Swiss drugmaker that’s won the first FDA green light.
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved TabrectaTM (capmatinib) for treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Tabrecta, the first and only treatment approved to specifically target NSCLC with this driver mutation, is approved for first-line and previously treated patients regardless of prior treatment type.