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

 ­ Ref: PRNewswire | Image: The Print