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Merck KGaA: FDA Granted Breakthrough Therapy Designation For Tepotinib

German science and technology company Merck KGaA (MKGAY.PK) announced Wednesday that the US Food and Drug Administration has granted Breakthrough Therapy Designation for the investigational targeted therapy tepotinib.

The therapy is for patients with metastatic non-small cell lung cancer or NSCLC harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy.

Discovered in-house at Merck KGaA, tepotinib is an investigational oral MET kinase inhibitor.

The Breakthrough Therapy Designation is based on data from the ongoing VISION study (NCT02864992), showing preliminary clinical evidence that tepotinib may offer an improvement over available therapy.

Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, said, "Tepotinib was associated with robust objective responses with durability that has not previously been seen in patients with metastatic NSCLC harboring MET exon 14 skipping alterations, selected by either tissue or liquid biopsy approaches."

In March 2018, the Japanese Ministry of Health, Labour and Welfare granted SAKIGAKE 'fast-track' designation for tepotinib in advanced NSCLC harboring MET exon 14 skipping alterations.

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