AbbVie Gets FDA Priority Review for Imbruvica/Rituximab Combo
June 25 2018 - 10:04AM
Dow Jones News
By Colin Kellaher
AbbVie Inc. (ABBV) on Monday said the Food and Drug
Administration accepted for priority review a supplemental New Drug
Application for Imbruvica in combination with rituximab as a new
treatment option for an incurable form of blood cancer.
The North Chicago., Ill., biopharmaceutical company said the
sNDA, if approved, would expand the FDA's prescribing information
for Imbruvica in Waldenstrom's macroglobulinemia, or WM, as the
first chemotherapy-free combination treatment option.
AbbVie said the filing is based on data from a Phase 3 study
that suggests Imbruvica plus rituximab may improve outcomes across
all lines of WM treatment, including patients with prior lines of
therapy and various genetic factors, versus rituximab alone. Roche
Holding AG (ROG.EB) markets rituximab under the name Rituxan.
Imbruvica, a cancer drug jointly developed and commercialized by
units of AbbVie and Johnson & Johnson (JNJ), is currently
approved for use as a single agent in WM, a rare and incurable form
of non-Hodgkin's lymphoma.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
June 25, 2018 09:49 ET (13:49 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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