Novartis Scemblix Granted FDA Priority Review For The Treatment Of Adults With Newly Diagnosed CML

Author: Benzinga Newsdesk | July 29, 2024 12:10pm

https://www.novartis.com/news/media-releases/novartis-scemblix-granted-fda-priority-review-treatment-adults-newly-diagnosed-cml

 

• Priority Review based on ASC4FIRST Phase III study with Scemblix® data first to show significantly improved molecular response and a favorable safety and tolerability profile compared to standard of care therapies (imatinib and 2G TKIs)1 
  
   
• Treatment options combining high efficacy with safety and tolerability represent a critical gap in care for long-term CML management1
  
   
• Scemblix was previously granted FDA Breakthrough Therapy designation and is in review under the agency's Real-Time Oncology Review program2-4

East Hanover, July 29, 2024 – Novartis announced today that Scemblix® (asciminib) has been granted Priority Review status by the US Food and Drug Administration (FDA) for treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP).

The FDA grants Priority Review to medicines that address serious or life-threatening diseases or conditions and, if approved, would provide significant improvements in treatment safety or efficacy5. Scemblix previously received Breakthrough Therapy designation for the treatment of newly diagnosed adult patients and is currently being reviewed under the FDA's Real-Time Oncology Review (RTOR) program. Scemblix received Priority Review and Breakthrough Therapy designations at the time of the original new drug application for the treatment of adult patients with Ph+ CML-CP who have previously been treated with two or more TKIs2-4,6,7.

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