Libtayo (cemiplimab) from Regeneron and Sanofi receives FDA approval for the treatment of advanced cutaneous squamous cell carcinoma.
Over 160 PD-1/L1 drugs are currently in development (preclinical through marketing), according to the Cancer Research Institute. The sixth PD-1/L1 in the world to receive marketing approval comes from Sanofi and Regeneron. Their drug, Libtayo (cemiplimab) recently received US Food and Drug Administration (FDA) approval for the treatment of advanced cutaneous squamous cell carcinoma (CSCC).
Libtayo was approved under an accelerated pathway based on positive results for clinical studies. According to oncologist Danny Rischin, even some elderly patients with comorbidities that were estimated to have just a few months left are living normal lives nearly two years later.
Both Regeneron and Sanofi invested $1 billion each to accelerate the develop program for cemiplimab in order to more rapidly get into the market and compete with highly successful PD-1/L1 drugs from Merck and Bristol-Myers Squibb. They plan to price a three-week treatment cycle at $9,100, although patients will be eligible for copay support.
Roche, AstraZeneca and Pfizer/Merck KGaA are also developing PD-1/L1 drugs.
