Merck announces FDA breakthrough therapy designation for investigational therapy tepotinib in patients with metastatic NSCLC with METex14 skipping alterations

Merck Serono

11 September 2019 - Investigational oral MET inhibitor has previously received SAKIGAKE ’fast-track’ regulatory designation in Japan.

Merck today announced that the US FDA has granted breakthrough therapy designation for the investigational targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) harbouring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy.

The breakthrough therapy designation is based on data from the ongoing VISION study, showing preliminary clinical evidence that tepotinib may offer an improvement over available therapy in patients with metastatic NSCLC harbouring MET exon 14 skipping alterations detected by liquid biopsy or tissue biopsy across different lines of treatment.

Read Merck press release

Michael Wonder

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Michael Wonder