The FDA has just announced that Libtayo is now officially the first and only form of treatment for patients with cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who do not qualify for courses of radiation or surgery.
In a press release, Michael R. Migden, M.D., Professor at The University of Texas MD Anderson Cancer Center and lead investigator in the pivotal CSCC clinical program, said: “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. Libtayo is an important new immunotherapy option for U.S. physicians to help address a significant unmet need in this patient group.”
This new drug is part of the recent wave of checkpoint inhibitors designed to target the PD-1/PD-L1 pathway. So far, they have shown a lot of promise in treating a variety of tumors, including melanoma, non-small cell lung cancer, kidney cancer, bladder cancer, head and neck cancers, and Hodgkin lymphoma.
In clinical trials, Libtayo has managed to reach an efficiency of almost 50%, shrinking or completely removing tumors in about half of the 108 patients enrolled.
Right from the start of the evaluation process, the FDA has recognized the importance of this medicine, granting it Breakthrough Therapy Designation in and Priority Review. These are special labels offered to drugs that present significant improvements in safety or efficacy in treating serious conditions.
Olivier Brandicourt, M.D. and Chief Executive Officer of Sanofi, the company that produces the drug, stated that: “In the U.S., CSCC accounts for one in five skin cancers, and the number of new diagnoses is increasing. We believe Libtayo has the potential to make a difference for U.S. patients with advanced CSCC, as it helps to fill a critical gap in treatment options. We are committed to bringing this important medicine to patients in other countries around the world as quickly as possible“.