The FDA gives Sanofi and Regeneron approval to use before and after pictures in drug marketing for a cutaneous squamous cell carcinoma treatment.
Libtayo (cemiplimab-wrlc) is a monoclonal antibody in the PD-1/PD-L1 class of anti-cancer drugs. It is the first drug approved by the U.S. Food and Drug Administration (FDA) (September 2018) 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. This is the first FDA approval of a drug specifically for advanced CSCC, the second most common form of skin cancer.
The FDA has also given the marketers of Libtayo (Sanofi and Regeneron) approval to use before and after pictures of patients with CSCC who have been treated with Libtayo. No other PD-1/PD-L1 inhibitor has been granted this permission,
The visual strategy is effective, according to Regeneron’s oncology business unit vice president E.B. Brakewood, particularly with nose and head and neck surgeons, who “speak a different language from the medical oncologist” and “see and deal with pictures much more.”
Sanofi and Regeneron are also using non-traditional methods for presenting data, including spider plots to show how the size of individual patient tumors change over time and waterfall plots to indicate patient responses to treatment.
Libtayo is currently in clinical trials for lung cancer. If it has positive results and gains FDA approval, the drug will compete with Merck’s Keytruda, which is the current market leader, as well as a newly approved drug from Roche and possibly products from Bristol-Myers Squibb and AstraZeneca.