Genentech Submits Application for Venclexta Plus Gazyva for Chronic Lymphocytic Leukemia
March 07 2019 - 9:29AM
Dow Jones News
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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