Roche (QX) (USOTC:RHHBY)
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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.
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(END) Dow Jones Newswires
January 27, 2020 07:46 ET (12:46 GMT)
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