Shots:

• The MAA is based on a P-II VISION study assessing Tepotinib as monothx. in patients with advanced NSCLC of METex14 skipping alterations- prospectively assessed by liquid biopsy or tissue biopsy
• With the validation- the application is complete- and the EMA will now initiate the review procedure.
• Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET alteration. The FDA is reviewing the application under PR and through the Real-Time Oncology Review pilot program

 ­ Ref: PRNewswire | Image: Merck KGaA