Posted by Michael Wonder on 30 Jul 2024
Novartis Scemblix granted FDA priority review for the treatment of adults with newly diagnosed CML
29 July 2024 - Priority review based on ASC4FIRST Phase 3 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 second generation tyrosoine kinase inhibitors).
Novartis announced today that Scemblix (asciminib) has been granted priority review status by the US FDA for treatment of newly diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase.
