Roche's Tecentriq Gets FDA Priority Review With Celgene's Abraxane

   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 [e-mail]; @donatopmancini

(END) Dow Jones Newswires

November 13, 2018 01:28 ET (06:28 GMT)

Copyright (c) 2018 Dow Jones & Company, Inc.