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

August 3, 2021 Auto Bot atezolizumab, BLA, FDA, NSCLC, Priority Review, regulatory, Roche, Tecentriq 0

Shots:

  • 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

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