Roche's Tecentriq Gets FDA Priority Review With Celgene's Abraxane
November 13 2018 - 1:43AM
Dow Jones News
By Donato Paolo Mancini
Roche Holding AG's (ROG.EB) Tecentriq has been granted U.S. Food
& Drug Administration priority review status in combination
with Abraxane for the treatment of a type of breast cancer, the
company said Tuesday.
FDA priority reviews are granted to treatments that are
determined to have the potential to provide significant
improvements in treatment, prevention, or diagnosis of a
disease.
The review for the initial, or first-line, treatment of
unresectable locally advanced or metastatic triple-negative breast
cancer would be for those patients whose disease expresses a
protein called PD-L1, Roche said.
If approved, the company said this combination would be the
first cancer immunotherapy regimen for that type of cancer.
Abraxane is a registered trademark of Abraxis Bioscience, LLC,
which is wholly owned by Celgene Corp. (CELG).
The FDA is expected to make a decision on approval by March 12,
2019, Roche said.
Write to Donato Paolo Mancini at
donatopaolo.mancini@dowjones.com; @donatopmancini
(END) Dow Jones Newswires
November 13, 2018 01:28 ET (06:28 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
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