Roche's Genentech Gets FDA Breakthrough Designation for Tiragolumab Combo

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 [e-mail]

(END) Dow Jones Newswires

January 05, 2021 06:53 ET (11:53 GMT)

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