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

February 10, 2021 Auto Bot Advanced, approval, FDA, patients, receives, Regeneron, regulatory 0

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

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