- 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
Click here to read full press release/ article | Ref: PRNewswire | Image: FIerce Pharma