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