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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