Tabrecta Approval Offers New Hope For Non-Small Cell Lung Cancer Patients
May 6, 2020- The U.S. Food and Drug Administration (FDA) today approved Tabrecta (capmatinib) for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring a jump mutation in exon 14 of MET.
This approval provides the first targeted treatment option for this specific patient population.
About Tabrecta
Tabrecta is an oral MET inhibitor developed by Novartis that specifically targets the MET exon 14 jump mutation.
Tabrecta is an oral MET inhibitor developed by Novartis that specifically targets the MET exon 14 jump mutation, which accounts for approximately 3-4% of NSCLC and is associated with poor prognosis.
Tabrecta inhibits tumor growth and spread by blocking the MET signaling pathway.
EU Approval
In June 2022, the European Commission approved Tabrecta® as monotherapy for adult patients with advanced NSCLC with the METex14 jump mutation who have received prior systemic therapy, including immunotherapy and/or platinum-based chemotherapy.
This approval is based on the results of the Phase II clinical study GEOMETRY mono-1, which showed that the overall remission rate (ORR) for cimatinib was 44% in previously treated patients, including 51.6% in patients treated with second-line therapy
China Approval
On June 12, 2024, the National Drug Administration (NMPA) formally approved the marketing of Tabrecta® for use in adult patients with locally advanced or metastatic NSCLC carrying the METex14 jump mutation without systemic therapy.
This approval is primarily based on data from GeoMETry mono-1, a global multicenter clinical study, and GeoMETry-C, a registry-based clinical study for the Chinese population.
The GeoMETry-C study showed that the objective remission rate (ORR) of cimatinib in first-line treatment of patients with advanced NSCLC with the METex14 jump mutation was 53.3%, and in patients with brain metastases Complete remission rates of 50% were observed for intracranial lesions.
U.S. Approval
On May 6, 2020, the U.S. Food and Drug Administration (FDA) approved the marketing of Tabrecta® for the treatment of patients with locally advanced or metastatic NSCLC with METex14 mutations.
This approval was based on data from the Phase II trial GEOMETRY mono-1, which showed that Tabrecta® had an overall remission rate (ORR) of 68% in first-treatment patients and 41% in patients who had received prior therapy
However, HK DengYue’s efforts to increase the affordability of the medicine are critical to ensuring that more patients benefit from it.
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