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(RTTNews) - Novartis AG (NVS) Thursday announced that the FDA has granted Breakthrough Therapy designation to Scemblix for treating adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia or CML in chronic phase. This is the third Breakthrough Therapy designation assigned to Scemblix.

The designation is based on positive data from the Phase III ASC4FIRST study, in which Scemblix met both primary endpoints, compared to imatinib alone. In comparison with standard-of-care drugs, Scemblix demonstrated a favorable safety and tolerability profile.

Breakthrough Therapy designation is usually to a drug compound that targets a serious or life-threatening disease and demonstrates a potential substantial improvement over existing therapies.

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