Novartis's Scemblix Granted FDA Priority Review

By Adam Whittaker

Novartis's treatment Scemblix has been granted priority review status by the U.S. Food and Drug Administration for adults with newly diagnosed Philadelphia chromosome-positive Chronic myeloid leukemia.

The decision follows a Phase 3 study which showed the treatment significantly improved molecular response and a had favorable safety and tolerability profile compared with standard of care therapies.

Scemblix is currently approved by the FDA, European Medicines Agency and other regulatory authorities for adult patients with the condition who have been treated previously with two or more tyrosine kinase inhibitors.

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(END) Dow Jones Newswires

07-29-24 1235ET