Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

 Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post