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

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

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

Shots:

  • 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

Click here to read full press release/ article | Ref: Sanofi | Image: Lung Disease News

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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