Genentech Tecentriq Gets Priority Review in Advanced Non-Small Cell Lung Cancer

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.

https://www.marketscreener.com/ROCHE-HOLDING-AG-9364975/news/Roche-Genentech-Gets-FDA-Priority-Review-for-Tecentriq-in-Advanced-Non-Small-Cell-Lung-Cancer-30018253/