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

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

Click here ­to­ read full press release/ article | Ref: Roche | Image: Bloomberg