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
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 firstname.lastname@example.org
(END) Dow Jones Newswires
January 05, 2021 06:53 ET (11:53 GMT)
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