NVS Novartis AG

By Colin Kellaher

Novartis AG on Monday said the U.S. Food and Drug Administration granted a pair of breakthrough-therapy designations to asciminib, its investigational treatment specifically targeting the ABL myristoyl pocket in chronic myeloid leukemia.

The Swiss drug maker said the designations cover asciminib for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase who were previously treated with two or more tyrosine kinase inhibitors, and those who harbor the T315I mutation.

The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.

Novartis, which is developing asciminib across multiple treatment lines of chronic myeloid leukemia, said it plans to file for U.S. Food and Drug Administration approval in pre-treated patients in the first half of the year.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 08, 2021 08:17 ET (13:17 GMT)

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