Roche's novel anti-TIGIT tiragolumab gains FDA 'Breakthrough' status

Swiss pharma giant Roche’s (ROG: SIX) novel cancer immunotherapy tiragolumab has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration, in combination with Tecentriq (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression with no EGFR or ALK genomic tumor aberrations.

Tiragolumab is the first anti-TIGIT molecule to be granted the coveted BTD from the FDA, according to Roche, and the designation is based on randomized data from the Phase II CITYSCAPE trial. CITYSCAPE provides the first evidence that targeting both immune inhibitory receptors, TIGIT and PD-L1, may enhance anti-tumor activity by potentially amplifying the immune response.

Growing interest