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Roche's Tecentriq Receives the US FDA's Approval as 1L Monotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

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Roche's Tecentriq Receives the US FDA's Approval as 1L Monotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

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  • The US FDA has approved Tecentriq (atezolizumab) as a 1L Treatment for adults with metastatic NSCLC whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells or PD-L1 stained tumor-infiltrating covering ≥ 10% of the tumor area)- as determined by an FDA-approved test- with no EGFR or ALK genomic tumor aberrations
  • The approval is based on an interim analysis from the Phase III IMpower110 study assessing Tecentriq as monothx. vs cisplatin/ carboplatin and pemetrexed/ gemcitabine (CT) in 572 PD-L1-selected- CT-naïve participants in ratio (1:1) with stage IV non-sq. or sq. NSCLC
  • The P-III IMpower110 study results: improvement in OS by 7.1mos. median OS (20.2 vs 13.1 mos.); safety is consistent with the known safety profile; no new safety profile was identified. The approval marks Tecentriq’s fourth indication in mNSCLC and fifth indication in lung cancer in the US

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Ref: Roche  | Image: Roche  

 


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