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Domestic approval of Tabrecta is imminent

By Eo, Yun-Ho | translator Choi HeeYoung

21.11.17 18:48:30

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Expectations are rising, such as the MFDS' final approval review and future combination therapy

Validation of MET Exxon14 mutated metastatic non-small cell lung cancer


According to related industries, the MFDS is conducting a final review for marketing approval of Tabrecta (Capmatinib) of Novartis Korea. Approval is possible within this year. MET mutations account for about 3% to 4% of metastatic non-small cell lung cancer, and as there have been no treatments, interest in these new drugs is increasing.

Tabrecta targets hepatocyte growth factor receptor (c-Met) and was first approved in the United States in May last year as a treatment for MET exon14 mutated metastatic non-small cell lung cancer (NSCLC). It was confirmed to be effective through a phase 2 GEOMETRY mono-1 study of 97 patients with METex14.

As a result of the study, the overall response ra

Eo, Yun-Ho(unkindfish@dailypharm.com)
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