By Michael Dabaie

 

Roche Holding AG's (RHHBY) Genentech said Thursday it submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for Venclexta in combination with Gazyva in people with previously untreated chronic lymphocytic leukemia.

Venclexta is being developed by AbbVie (ABBV) and Genentech.

The FDA is reviewing the application under the Real-Time Oncology Review pilot program, which aims to explore a more efficient review process.

FDA granted breakthrough therapy designation based on results of the randomized Phase III CLL14 study, evaluating the fixed-duration combination of Venclexta plus Gazyva, compared to Gazyva plus chlorambucil, in people with previously untreated CLL and co-existing medical conditions. The study met its primary endpoint and showed a statistically significant reduction in the risk of disease worsening or death compared to standard-of-care Gazyva plus chlorambucil.

 

Write to Michael Dabaie at michael.dabaie@wsj.com

 

(END) Dow Jones Newswires

March 07, 2019 09:14 ET (14:14 GMT)

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