Novartis Gets FDA Breakthrough-Therapy Designation for Asciminib
February 08 2021 - 8:32AM
Dow Jones News
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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