Gilead Sciences Unit Gets FDA Priority Review for KTE-X19
February 10 2020 - 9:11AM
Dow Jones News
By Colin Kellaher
Gilead Sciences Inc. (GILD) on Monday said the U.S. Food and
Drug Administration granted priority review to the biologics
license application for its Kite unit's KTE-X19 for adults with
relapsed or refractory mantle cell lymphoma, a rare form of
non-Hodgkin lymphoma.
The Foster City, Calif., biopharmaceutical company said the
filing is supported by data from a Phase 2 study in which 93% of
patients responded to a single infusion of KTE-X19, including 67%
who achieved a complete response.
The FDA grants priority review to medicines that have the
potential to provide significant improvements in the treatment of a
serious disease, and the designation shortens the review period to
six months from the standard 10 months.
Gilead said the agency set a target action date of Aug. 10 for
the application.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 10, 2020 08:56 ET (13:56 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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