Genentech Gets FDA Priority Review for Tecentriq in Advanced Non-Small Cell Lung Cancer
February 19 2020 - 6:36AM
Dow Jones News
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)
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