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

Shots:

• 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