By Colin Kellaher
Roche Holding AG's Genentech unit on Tuesday said the U.S. Food and Drug Administration granted breakthrough-therapy designation to tiragolumab in combination with the company's cancer drug Tecentriq in a form of lung cancer.
Genentech said the designation covers the first-line treatment of people with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.
The FDA's breakthrough-therapy designation aims to expedite the development and review of a drug for serious conditions when preliminary clinical evidence shows the drug may show substantial improvement over available therapies.
Genentech said tiragolumab, a novel cancer immunotherapy designed to bind to the human protein TIGIT, is the first anti-TIGIT molecule to receive the designation.
TIGIT and the PD-L1 protein play a role in the suppression of the immune system, and blocking both pathways simultaneously with tiragolumab and Tecentriq has the potential to increase anti-tumor activity by enhancing the body's immune response to cancer cells, the company said.
Genentech said a randomized Phase II study has shown encouraging efficacy and safety with the combination in people with PD-L1-positive metastatic non-small cell lung cancer.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
01-05-21 0653ET