Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

 Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receive the US FDA’s Approval as 1L Treatment for Advanced NSCLC

Shots:

  • The approval is based on the P-III EMPOWER-Lung 1 trial assessing Libtayo (350mg, q3w) monothx. vs platinum doublet CT in 710 patients for the 1L treatment with advanced NSCLC who tested positive for PD-L1 in ≥50% of tumor cells and without EGFR, ALK or ROS1 aberrations
  • The study showed a 32% reduction in the risk of death; mOS (22mos. vs 14mos.); mPFS per BICR (6.2 vs 5.6mos.). An additional prespecified analysis was performed in 563 patients with proven PD-L1 expression of ≥50% and showed a 43% reduction in risk of death
  • Libtayo is a fully human mAb targeting the immune checkpoint receptor PD-1 on T-cells. This approval marks the third approval in the US

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: STAT

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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