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Novartis Gets US FDA's Priority Review for Chronic Myeloid Leukemia Drug
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Novartis Gets US FDA's Priority Review for Chronic Myeloid Leukemia Drug
Jul 29, 2024 10:52 AM

01:24 PM EDT, 07/29/2024 (MT Newswires) -- Novartis ( NVS ) said Monday it has received priority review from the US Food and Drug Administration for Scemblix as a potential treatment for Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase in newly diagnosed adult patients.

The FDA's priority review designation is based on the results of a phase 3 study, which showed Scemblix demonstrating "superior" major molecular response rates and efficacy, as well as a favorable safety and tolerability profile, compared with standard of care therapies, the drugmaker said.

The FDA previously granted Scemblix a breakthrough therapy designation, the company said.

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