Genentech Seeks FDA OK for Tecentriq With Avastin in Common Form of Liver Cancer
January 27 2020 - 8:01AM
Dow Jones News
By Colin Kellaher
Roche Holdings AG's (ROG.EB) Genentech unit on Monday said it
filed a supplemental biologics license application with the U.S.
Food and Drug Administration for Tecentriq in combination with
Avastin in the most common form of liver cancer.
Genentech said the filing covers the treatment of people with
unresectable hepatocellular carcinoma who haven't received prior
systemic therapy.
The FDA is reviewed the filing under its Real-Time Oncology
Review pilot program, which aims to explore a more efficient review
process to ensure safe and effective treatments are available to
patients as early as possible.
Genentech is conducting an extensive development program for
Tecentriq, including ongoing and planned Phase 3 studies across
bladder, genitourinary, skin, breast, gastrointestinal,
gynecological and head and neck cancers.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
January 27, 2020 07:46 ET (12:46 GMT)
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