Novartis Gets FDA Breakthrough Therapy Designation for Scemblix

By Pierre Bertrand

Novartis said the U.S. drug regulator decided to expedite the development of Scemblix, to treat adults newly diagnosed with leukemia.

The Swiss pharmaceutical company said the U.S. Food and Drug Administration designated the treatment as a breakthrough therapy for the third time.

Drugs that get designated as breakthrough therapies are those designed to treat serious conditions and that have shown "that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s)," according to the FDA's website.

This latest designation was based off of the Phase III ASC4FIRST study, in which the drug met both of its primary endpoints, the company said.

Novartis will present the full findings of the study at the end of May.

Write to Pierre Bertrand at [e-mail]

(END) Dow Jones Newswires

05-10-24 0942ET