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Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…
October 9, 2025

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Insights+: EMA Marketing Authorization of New Drugs in February 2023
INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots:The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industryIn February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndromePharmaShots has compiled…
March 23, 2023

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Viewpoints_Ahmet Sezer, Karl Lewis, and Israel Lowy
VIEWPOINTS

PharmaShots Interview: Dr. Ahmet Sezer, Karl Lewis, and Regeneron’s Israel Lowy Share Insights on Libtayo (cemiplimab) for NSCLC & BCC

In an interview with PharmaShots, Dr. Ahmet Sezer, (Professor in the Department of Medical Oncology at Baskent University), Karl Lewis (Professor in the Division of Medical Oncology at the University of Colorado) and Israel Lowy (Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron) shared their views on the EC's approval of Libtayo for…
September 29, 2021

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Viewpoints_Dr. Sezer, Peter C. Adamson and Israel Lowy
VIEWPOINTS

PharmaShots Interview: Dr. Sezer, Peter C. Adamson and Israel Lowy Share Insight on the US FDA’s Approval of Libtayo (cemiplimab) in Patients with NSCLC with High PD-L1 Expression

Shots:In an interview with PharmaShots, Dr. Ahmet Sezer,  Sanofi's Peter C. Adamson, and Regeneron's Israel Lowy shared their views on the US FDA's approval of Libtayo and the data supporting the approval.Regeneron and Sanofi received the US FDA's approval for Libtayo for the 1L treatment of patients with advanced NSCLC whose tumors have high PD-L1 expression (tumor proportion score =50%), as…
March 30, 2021

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