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Roche Reports the US FDA's Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC

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Roche Reports the US FDA's Acceptance of BLA and Priority Review of Tecentriq (atezolizumab) as an Adjuvant Treatment for NSCLC

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  • The application is based on the P-III IMpower010 study evaluating the efficacy & safety of Tecentriq vs BSC in 1005 patients in a ratio (1:1) with Stage IB-IIIA NSCLC- following surgical resection and up to 4 cycles of adjuvant cisplatin-based CT
  • The results from an interim analysis showed the reduction in the risk of disease recurrence or death by 34% in patients with Stage II-IIIA NSCLC whose tumors express PD-L1≥1%- m- DFS (not reached vs 35.3 mos.) while safety data were consistent with its known safety profile and no new safety signals were observed
  • The application is being reviewed under the US FDA’s RTOR pilot program with anticipated FDA's decision on approval by Dec 01- 2021

Ref: Roche | Image: Roche

Click here to­ read the full press release 

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