Posted by Michael Wonder on 05 Jan 2021
Genentech’s novel anti-TIGIT tiragolumab granted FDA breakthrough therapy designation in combination with Tecentriq for PD-L1 high non-small cell lung cancer
4 January 2021 - Tiragolumab is the first anti-TIGIT therapy to be granted breakthrough therapy designation and marks the 37th breakthrough therapy designation for Genentech’s portfolio of medicines.
Genentech today announced that tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, has been granted breakthrough therapy designation by the U.S. FDA, in combination with Tecentriq (atezolizumab) for the first-line treatment of people with metastatic non-small cell lung cancer whose tumours have high PD-L1 expression with no EGFR or ALK genomic tumour aberrations.
Tiragolumab is the first anti-TIGIT molecule to be granted a breakthrough therapy from the FDA, 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-tumour activity by potentially amplifying the immune response.
