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Regeneron’s Libtayo (cemiplimab) Receives EMA’s CHMP Positive Opinion Recommending Approval to Treat Advanced Cervical Cancer

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Regeneron’s Libtayo (cemiplimab) Receives EMA’s CHMP Positive Opinion Recommending Approval to Treat Advanced Cervical Cancer

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  • The EMA’s CHMP has adopted a positive opinion for Libtayo as monothx. in adult patients with recurrent or metastatic cervical cancer. The EC’s decision is expected in the coming months
  • The opinion was based on the P-III (EMPOWER-Cervical 1) trial evaluating Libtayo (350mg, q3w) as monothx. vs CT in 608 patients. The trial met its 1EPs of OS with a 31% reduction in risk of death in the total population & 27% in the SCC population, no new Libtayo safety signals were observed, AEs (10%). The results were published in the NEJM
  • Libtayo is a fully human mAb targeting immune checkpoint receptor PD-1 on T cells developed using Regeneron's VelocImmune technology. The therapy was approved in the EU & other countries for BCC, advanced CSCC & NSCLC

Ref:  Regeneron Image:  Regeneron

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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