Novartis’ MET Inhibitor Tabrecta (capmatinib) Approved by European Commission for METex14 Skipping Mutation-Positive Advanced NSCLC
Novartis
Drug Development and Manufacturing
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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News on June 23, 2022 / BIOON / -- Novartis recently announced that the European Commission (EC) has approvedTargeted Anticancer Drug Tabrecta (capmatinib): This drug is an oral, potent, and selective MET kinase inhibitor, used as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) who require systemic therapy after receiving immunotherapy and/or platinum-based chemotherapy and carry MET exon 14 skipping (MET exon14 skipping, METex14) mutations.
In the United States, Tabrecta was approved in May 2020 for the treatment of adult patients with metastatic NSCLC carrying the METex14 mutation, including first-line treatment (treatment-naïve) patients and those who have previously received treatment (treatment-experienced), regardless of the type of prior treatment. Notably,Tabrecta is the first therapy approved by the U.S. FDA specifically for METex14 mutation-positive metastatic NSCLC.
The active pharmaceutical ingredient in Tabrecta is capmatinib, an inhibitor that targets MET kinase, including mutants generated by MET exon 14 skipping. MET exon 14 skipping results in the loss of regulatory domains in the protein, reducing its negative regulation and leading to increased downstream MET signaling, which promotes cancer cell proliferation and survival.
Capmatinib was licensed by Novartis from Incyte Corporation in 2009. Under the agreement, Incyte granted Novartis exclusive worldwide rights to develop and commercialize the compound and certain follow-up compounds for all indications.
Chemical Structure of Capmatinib (Source: medchemexpress.cn)
Globally,In the treatment of METex14 skipping mutation advanced NSCLC, Tabrecta is the top-prescribed targeted drug.METex14-mutated advanced NSCLC is a type of lung cancer with a very poor prognosis, and there is currently no established treatment specifically targeting this aggressive form of lung cancer. In the EU, it is estimated that there are 291,000 patients with locally advanced or metastatic NSCLC.METex14 skipping mutation is a recognized oncogenic driver, occurring in 3-4% of NSCLC cases.。
This approval is based on the results of the Phase 2 GEOMETRY mono-1 trial. The data showed that Tabrecta demonstrated a high overall response rate (ORR) in adult patients with advanced NSCLC whose tumors harbor METex14 mutations. Specifically:In the cohort primarily evaluating second-line patients, the ORR was 51.6%.；In all previously treated patients, the ORR was 44%.In the study, the most common treatment-related adverse events (AEs, incidence rate ≥20%) were peripheral edema, nausea, fatigue, increased blood creatinine, vomiting, dyspnea, decreased appetite, and back pain.
"GEOMETRY mono-1 trial principal investigator, Dr. Juergen Wolf from the Center for Integrated Oncology at University Hospital Cologne in Germany, stated: 'Lung cancer tumors carrying METex14 skipping mutations are often associated with poor prognosis and limited response to standard treatments, including immunotherapy. The approval of Tabrecta in Europe, along with advancements in biomarker testing technology, can help doctors more precisely guide treatment decisions. For patients with this specific genomic profile, there is now a new targeted treatment option.' (Bioon.com)"
Source of the original text:Novartis receives European Commission approval for Tabrecta® for the treatment of METex14 skipping advanced non-small cell lung cancer