Genentech Receives FDA Accelerated Approval for Cancer Treatment
August 15 2019 - 4:36PM
Dow Jones News
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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