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

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Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma

Shots:

  • The FDA approval is based on P-II trial involves assessing Libtayo (350mg, q3w) in patients with locally advanced BCC & metastatic BCC (nodal or distant)
  • Results: median follow-up (9.5 & 15.1mos.); ORR (21% & 29%); PR (21% & 23%); D0R @≥6mos. (100% & 79%); with longer follow up, 0RR with LA BCC (31%) as reported at ESMO 2020
  • Libtayo is a mAb targeting PD-1 on T-cells, currently under the US FDA’s PR for advanced NSCLC with an expected PDUFA date as Feb 28, 2021. EMA is assessing Libtayo in advanced NSCLC with ≥50% PD-L1 expression & LA BCC following treatment with HHI with anticipated EC’s decision in mid 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: The Print

The post Regeneron and Sanofi’s Libtayo (cemiplimab-rwlc) Receives US FDA’s Approval for Patients with Advanced Basal Cell Carcinoma first appeared on PharmaShots.