First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small cell lung cancer (NSCLC)
Approval based on survival benefit of TECENTRIQ compared to docetaxel chemotherapy, pill regardless of PD-L1 status
Genentech, site a member of the Roche Group (SIX: RO, drugs ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved 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 vs. 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.
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