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Roche’s Tecentriq Hybreza Receives the US FDA’s Approval for Cancer Treatment 

  Shots:   

  • The US FDA has approved Tecentriq Hybreza (SC) to treat all IV indications, incl. lung, liver, skin & soft tissue cancers. Regulatory reviews across other regions are underway 
  • The approval was supported by P-IB/III (IMscin001) study assessing Tecentriq Hybreza (SC) vs Tecentriq (IV) in locally advanced or metastatic NSCLC patients (n=371) failed on Pt therapy and P-II (IMscin002) assessing patient preference b/w SC vs IV in those (n=179) with PD-L1+ve resected Stage II-IIIB NSCLC & untreated Stage IV NSCLC 
  • IMscin001 trial showed consistent Tecentriq levels in blood with safety profile aligning with IV formulation. In the IMscin002 trial, 71% preferred SC over IV, with 79% opting to continue treatment with it 

Ref: Roche | Image: Roche| Press Release

Related News:- Johnson & Johnson Reports the US FDA’s Approval of Rybrevant + Lazcluze as a 1L Treatment of NSCLC with EGFR Mutations 

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