FDA gives thumbs up for Roche's Tecentriq for some patients with NSCLC

Swiss pharma giant Roche’s (ROG: SIX) subsidiary Genentech has received approval for the US Food and Drug Administration for Tecentriq (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.

This approval is based on results from the randomized Phase III OAK and Phase II POPLAR studies. The largest study, OAK, showed that Tecentriq helped people in the overall study population live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 versus 9.6 months; HR = 0.74, 95% CI: 0.63, 0.87). The study enrolled people regardless of their PD-L1 status and included both squamous and non-squamous disease types.

“Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” said Sandra Horning, chief medical officer and head of global product development. “Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works,” she pointed out.