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Roche:Tiragolumab-Tecentriq Gets FDA Breakthrough Therapy Designation For Non-small Cell Lung Cancer

Genentech, a member of the Roche Group (RHHBY), said that its novel anti-TIGIT Tiragolumab has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, in combination with Tecentriq for 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.

Genentech noted that Tiragolumab is the first anti-TIGIT therapy to be granted Breakthrough Therapy Designation and marks the 37th BTD for Genentech's portfolio of medicines.

The breakthrough therapy designation was based on the randomized Phase II CITYSCAPE study that showed encouraging efficacy and safety with tiragolumab plus Tecentriq or atezolizumab in people with PD-L1-positive metastatic non-small cell lung cancer.

The company noted that broad tiragolumab development program is ongoing across various settings in different tumor types, including lung, esophageal and cervical cancers.

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