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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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