Roche Reports the US FDA Acceptance of sBLA and Granted Priority Review for Tecentriq (atezolizumab) as 1L Monotherapy for Advanced Non-Small Cell Lung Cancer
Shots:
- The sBLA submission is based on P-III IMpower110 study assessing Tecentriq as monothx. vs CT in 572 PD-L1-selected (TC3/IC3-WT)- CT-naïve patients with advanced sq. or non-sq. NSCLC without ALK or EGFR mutations
- The P-III Impower110 study results: improvement in OS by 7.1mos. (20.2 vs 13.1mos.)- the safety profile is consistent with its known safety profile with no new signals observed
- Tecentriq is a mAb targeting PD-L1- blocking its interaction with both PD-1 and B7.1 receptor with its anticipated FDA’s decision on approval for this indication by Jun 19- 2020
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