Sanofi: FDA has approved Libtayo
(CercleFinance.com) - The US Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation.
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved and available for advanced CSCC in the US.
CSCC is the second most common form of skin cancer, which causes estimated 7,000 deaths each year in the US It currently accounts for approximately 20% of all skin cancers in the US, with the number of newly diagnosed cases expected to rise annually.
“Today's FDA decision is great news for patients with advanced CSCC, who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation,” said Michael R. Migden, M.D., a lead investigator in the pivotal CSCC clinical program and Professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and is the first and only treatment specifically approved and available for advanced CSCC in the US.
CSCC is the second most common form of skin cancer, which causes estimated 7,000 deaths each year in the US It currently accounts for approximately 20% of all skin cancers in the US, with the number of newly diagnosed cases expected to rise annually.
“Today's FDA decision is great news for patients with advanced CSCC, who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation,” said Michael R. Migden, M.D., a lead investigator in the pivotal CSCC clinical program and Professor in the Departments of Dermatology and Head and Neck Surgery at The University of Texas MD Anderson Cancer Center.
Copyright (c) 2018 CercleFinance.com. All rights reserved.