Genentech Receives FDA Accelerated Approval for Cancer Treatment

Date : 08/15/2019 @ 8:36PM
Source : Dow Jones News
Stock : Roche Holding (QX) (RHHBY)
Quote : 38.4  0.005 (0.01%) @ 9:13PM
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Genentech Receives FDA Accelerated Approval for Cancer Treatment

Roche Holding (QX) (USOTC:RHHBY)
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   By Dave Sebastian 
 

Genentech Inc. received accelerated approval for its Rozlytrek treatment for cancer with the NTRK genetic defect, the U.S. Food and Drug Administration said Thursday.

The treatment has gone through four clinical trials studying adults with tumors caused by the genetic defect, the FDA said. The trials demonstrated the ability to shrink tumors in 57% of patients and to eliminate them in 7.4% of patients.

FDA also approved Rozlytrek for its treatment of adults with non-small cell lung cancer with ROS1-positive tumors and has spread to other parts of the body.

"We're seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine," FDA Acting Commissioner Ned Sharpless said in a statement.

 

Write to Dave Sebastian at dave.sebastian@wsj.com

 

(END) Dow Jones Newswires

August 15, 2019 16:21 ET (20:21 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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