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Sanofi's Libtayo Receives the US FDA approval for Metastatic Cutaneous Squamous Cell Carcinoma (mCSCC)

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Sanofi's Libtayo Receives the US FDA approval for Metastatic Cutaneous Squamous Cell Carcinoma (mCSCC)

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  • The approval is based on the results of P-II EMPOWER-CSCC-1 study and P-I study 1423 (two advanced CSCC expansion cohorts) assessing Libtayo in patients with mCSCC- locally advanced CSCC or Combined CSCC enrolling ≥163 candidates
  • P-II EMPOWER-CSCC-1 study & P-I study 1423 Results: ORR (47%- 49%- 47%); CRR (5%- 0%- 4%); PRR (41%- 49%- 44%)- showing its safety and efficacy
  • Libtayo is a fully human mAb targeting PD-1 receptor and approved for CSCC in the US with recommended dose 350 mg IV infusion over 30 min every three weeks

/ article | Ref: Sanofi | Image: Lung Disease News


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