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Regeneron and Sanofi's Libtayo (cemiplimab) Receives European Commission's Approval for Advanced Cutaneous Squamous Cell Carcinoma

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Regeneron and Sanofi's Libtayo (cemiplimab) Receives European Commission's Approval for Advanced Cutaneous Squamous Cell Carcinoma

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  • The conditional marketing authorization is based on the results from P-II EMPOWER-CSCC-1 (Study 1540) and supported by two advanced CSCC expansion cohorts from P-I study evaluating a Libtayo in patients with advanced CSCC
  • The conditional approval is to meet unmet needs in advance CSCC- and the companies will generate additional data supporting the benefit-risk profile of Libtayo and report it to EMA for full approval
  • Libtayo (350mg- q3w) is a mAb targeting the immune checkpoint receptor PD-1 and an approved therapy in the US- EU- Canada & Brazil for patients with metastatic/LA CSCC candidates ineligible for curative surgery/radiation

Click here to read full press release/ article | Ref: Sanofi Genzyme | Image: Investopedia


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