Novartis AG announced on Thursday that the FDA has bestowed Scemblix with the Breakthrough Therapy designation. This is intended for adult patients newly diagnosed with Philadelphia chromosome-positive chronic myeloid leukemia (CML) in its chronic phase. Notably, this is the third time Scemblix receives such acknowledgment.
The designation follows favorable results from the Phase III ASC4FIRST study, where Scemblix successfully met both primary objectives, even outperforming imatinib on its own. When set against standard-of-care drugs, Scemblix showed impressive safety and tolerability standards.
To clarify, the Breakthrough Therapy designation is granted to drug compounds that target severe or life-threatening diseases. The compound must also demonstrate a substantial potential for improvement compared to currently available treatments.
At present, Novartis AG's shares are valued at $101.42, a 1.2% rise from the prior close at $100.21. The current volume stands at 176,838.
