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| Name | Symbol | Market | Type |
|---|---|---|---|
| Roche Holdings Ltd AG (QX) | USOTC:RHHBY | OTCMarkets | Depository Receipt |
| Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.23 | 0.77% | 30.25 | 30.15 | 30.26 | 30.28 | 30.07 | 30.10 | 2,908,982 | 22:20:00 |
From Apr 2019 to Apr 2024
By Colin Kellaher
Roche Holding AG's Genentech unit on Wednesday said the U.S. Food and Drug Administration accepted for priority review the company's supplemental biologics license application as a first-line monotherapy for certain forms of advanced non-small cell lung cancer.
Genentech said the application covers Tecentriq for people with advanced non-squamous and squamous non-small cell lung cancer without EGFR or ALK mutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.
Genentech said the agency set a target action date of June 19 for the application.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
February 19, 2020 06:21 ET (11:21 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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