Sanofi: FDA to Review Isatuximab for Relapsed/Refractory Multiple Myeloma
July 10 2019 - 7:05AM
Dow Jones News
By Colin Kellaher
Sanofi S.A. (SAN.FR, SNY) Wednesday said the U.S. Food and Drug
Administration accepted for review the company's biologics license
application for isatuximab for patients with relapsed/refractory
multiple myeloma.
The Paris drug maker said the agency set a target action date of
April 30, 2020.
Multiple myeloma, a cancer that forms in a type of white blood
cell called a plasma cell, affects more than 138,000 people
worldwide. The disease causes cancer cells to accumulate in the
bone marrow, where they crowd out healthy blood cells, according to
the Mayo Clinic.
Sanofi said its FDA filing is based on results of a phase 3
trial in which isatuximab added to pomalidomide and dexamethasone
showed a 40% reduction in the risk of disease progression or death
for patients with relapsed/refractory multiple myeloma compared
with pomalidomide and dexamethasone alone.
Sanofi said it is studying isatuximab in multiple phase 3 trials
in combination with current standard treatments for people with
relapsed/refractory or newly-diagnosed multiple myeloma.
The drug previously received orphan designation for
relapsed/refractory multiple myeloma from the FDA and from the
European Medicines Agency, which accepted Sanofi's marketing
authorization application in the second quarter.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect less than 200,000
people in the U.S. and provides for a seven-year marketing
exclusivity period against competition.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
July 10, 2019 06:50 ET (10:50 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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